Natus Medical Incorporated
San Diego, CA, US
Natus Medical Incorporated appears in FDA device records in San Diego, CA. FDA records list 23 510(k) clearances between and , 11 PMA records and 2 registered establishments. As of , FDA records show 31 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Natus Medical Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Integra Neuro Sciencesrecall
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)registration, 510(k)
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)enforcement report, recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Natus Medical Incorporated between 2010 and 2024. The busiest year on record is 2018, with 7. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 7 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242930 | Natus BrainWatch System | OMC | Substantially Equivalent | |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | GWJ | Substantially Equivalent | |
| K203500 | RetCam Envision | HKI | Substantially Equivalent | |
| K200878 | Natus NeuroWorks | OMB | Substantially Equivalent | |
| K182178 | neoBLUE blanket LED Phototherapy System | LBI | Substantially Equivalent | |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | HKI | Substantially Equivalent | |
| K173936 | Natus Photic Stimulator | GWE | Substantially Equivalent | |
| K180290 | Natus Brain Monitor Amplifier | GWQ | Substantially Equivalent | |
| K180421 | Natus NeuroWorks | OMB | Substantially Equivalent | |
| K173690 | Grass TWin | OLV | Substantially Equivalent | |
| K180181 | Natus Quantum | GWQ | Substantially Equivalent | |
| K172711 | Comet-PLUS | OLV | Substantially Equivalent | |
| K163163 | XLTEK EMU40EX EEG Headbox | GWQ | Substantially Equivalent | |
| K160745 | neoBLUE compact LED Phototherapy System | LBI | Substantially Equivalent | |
| K162595 | Trex_HD | GWQ | Substantially Equivalent | |
| K152301 | Background Pattern Classification [BPc(TM)] | OMA | Substantially Equivalent | |
| K160305 | neoBLUE® LED Phototherapy System | LBI | Substantially Equivalent | |
| K143440 | Natus Quantum | GWQ | Substantially Equivalent | |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | GWJ | Substantially Equivalent | |
| K112247 | A BAER WITH ABAER I/O FUNCTION | EWO | Substantially Equivalent | |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | EWO | Substantially Equivalent | |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | LBI | Substantially Equivalent | |
| K100683 | NEUROLINK IP MODEL: PK1117 | GWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612330 | 3002809369 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) | 2568 BRISTOL CIR., OAKVILLE Ontario L6H 5S1 CA | 2026 | and 10 more, listed in full below |
| 2023988 | 2023988 | Natus Medical Incorporated | 6225 Nancy Ridge Dr, SAN DIEGO, CA 92121 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OMAAmplitude-Integrated Electroencephalograph
- EWOAudiometer
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
- ORTBurst Suppression Detection Software For Electroencephalograph
- IKDCable, Electrode
- HKICamera, Ophthalmic, Ac-Powered
- MXMCap, Cooling (Infants)
- GWMDevice, Monitoring, Intracranial Pressure
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- GYCElectrode, Cortical
- GXYElectrode, Cutaneous
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- GYKInstrument, Shunt System Implantation
- PSPIntracranial Pressure & Temperature Monitoring Kit
- BZQMonitor, Breathing Frequency
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular
- OMCReduced- Montage Standard Electroencephalograph
- JXGShunt, Central Nervous System And Components
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
- PIYStainless Steel Instrument, Shunt System Implantation
- OLVStandard Polysomnograph With Electroencephalograph
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GWEStimulator, Photic, Evoked Response
- CCXSupport, Patient Position
- LLZSystem, Image Processing, Radiological
- LBIUnit, Neonatal Phototherapy
- MNRVentilatory Effort Recorder
Recall records
Showing 25 of 31| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2138-2025 | Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph | Natus received two complaints of left side labeling show impedance for right side. | Class II | Open, Classified | |
| Z-1925-2025 | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device. | Class II | Open, Classified | |
| Z-0635-2024 | EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. | Class II | Open, Classified | |
| Z-0634-2024 | External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. | Class II | Open, Classified | |
| Z-0735-2023 | The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF). | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable. | Class II | Open, Classified | |
| Z-0661-2022 | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software | Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user. | Class II | Terminated | |
| Z-1630-2020 | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items. | Class II | Terminated | |
| Z-2737-2018 | Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation. | Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail. | Class II | Terminated | |
| Z-2570-2018 | XLTEK EMU40EX EEG Headbox | Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting. | Class II | Terminated | |
| Z-2701-2017 | The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160 - ~170 F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW 208/120V) 007169 PM3000 ASSY (9KW 208/120V) 007169R PM3 (9KW 208/120) REFURB 007170 PM3 ASSY (8.3KW 200V DELTA) 007171 PM3 ASSY (9KW 220V SING PH) 52640 PASTEURMATIC 3000 W/O BASKETS 52640R PM 3000 w/o Baskets Refurb 52640-200 PM 3000 W/O BASKETS 200V 52640-220 PM 3000 W/O BASKETS 220V 52641 PASTEURMATIC 3000 W/BASKET S 52641R PM 3000 w/ Baskets Refurb 52641-200 PM 3000 W BASKETS 200V 52641-220 PM 3000 W/ BASKETS 220V 52650 PASTEURMATIC 3500 W/O BASKET 52651 PASTEURMATIC 3500 W/BASKETS S | Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices. | Class II | Terminated | |
| Z-1924-2017 | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia. | The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver. | Class II | Terminated | |
| Z-0770-2017 | Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS | neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box. | Class II | Terminated | |
| Z-0769-2017 | Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected. 2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life. Affected Part Numbers and Description: 006244 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS | The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box. | Class II | Terminated | |
| Z-0056-2017 | The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007. | NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment. | Class II | Terminated | |
| Z-1878-2016 | Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01. | The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents. | Class II | Terminated | |
| Z-2001-2016 | Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia | The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device. | Class II | Terminated | |
| Z-1363-2016 | Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. | NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator. | Class II | Terminated | |
| Z-0581-2016 | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. | Class II | Terminated | |
| Z-0149-2016 | Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103 | The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission. | Class II | Terminated | |
| Z-1412-2015 | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS | neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box. | Class II | Terminated | |
| Z-1068-2015 | EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege. | Class II | Terminated | |
| Z-1067-2015 | EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery. | Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege. | Class II | Terminated | |
| Z-0847-2015 | Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy. | Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired. | Class II | Terminated | |
| Z-1843-2012 | Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***" | Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment. | Class II | Terminated | |
| Z-0447-2013 | The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***" | The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain