Laerdal Medical a/S
Wappingers Falls, NY, US
LAERDAL MEDICAL A/S appears in FDA device records in Wappingers Falls, NY. FDA records list 20 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Laerdal Medical a/S between 1982 and 2025. The busiest year on record is 1996, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2012 | 1 |
| 2015 | 2 |
| 2018 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | BTM | Substantially Equivalent | |
| K232111 | NeoBeat, NeoBeat Mini | MWI | Substantially Equivalent | |
| K183348 | Reusable Silicone Cover CPRmeter 2 | LIX | Substantially Equivalent | |
| K173886 | CPRmeter 2 CPR Feedback Device | LIX | Substantially Equivalent | |
| K151702 | Reusable Full Silicone Cover | LIX | Substantially Equivalent | |
| K132172 | NEONATALIE RESUSCITATOR | BTM | Substantially Equivalent | |
| K122050 | CPRMETER CPR FEEDBACK DEVICE | LIX | Substantially Equivalent | |
| K023805 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | CBP | Substantially Equivalent | |
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | CBP | Substantially Equivalent | |
| K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | BTA | Substantially Equivalent | |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | BSR | Substantially Equivalent | |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | BSR | Substantially Equivalent | |
| K954609 | HEARTSTART 911 | MKJ | Substantially Equivalent | |
| K950698 | LSU 2000 PORTABLE SUCTION UNIT | JCX | Substantially Equivalent | |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | KGB | Substantially Equivalent | |
| K896919 | HEARTSTART 3000 | MKJ | Substantially Equivalent | |
| K880450 | RESUSCI PATIENT FACE SHIELD | BTM | Substantially Equivalent | |
| K861401 | LAERDAL POCKET MASK | CBP | Substantially Equivalent | |
| K840110 | LAERDAL SUCTION UNIT | BTA | Substantially Equivalent | |
| K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT | BTM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610483 | 3002807435 | LAERDAL MEDICAL A/S | Seehusens gate 1, STAVANGER Rogaland 4024 NO | 2026 | |
| 2425852 | 2425852 | LAERDAL MEDICAL CORP. | 167 Myers Corners Rd, Wappingers Falls, NY 12590 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LIXAid, Cardiopulmonary Resuscitation
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- MKJAutomated External Defibrillators (Non-Wearable)
- IQODevice, Prosthesis Alignment
- BYGMask, Oxygen
- KGBMask, Oxygen, Non-Rebreathing
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MRIOrthosis, Truncal/Orthosis, Limb
- BTAPump, Portable, Aspiration (Manual Or Powered)
- FPPStretcher, Hand-Carried
- NZDStretcher, Patient Restraint
- BSRStylet, Tracheal Tube
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1341-2026 | Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152; | units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M. | Class II | Open, Classified | |
| Z-0973-2018 | LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants. | A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms. | Class II | Terminated | |
| Z-1873-2017 | Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA) | The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged. | Class II | Terminated | |
| Z-0805-05 | LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack. | Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator. | Terminated | ||
| Z-0520-04 | Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway. | Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative. | Terminated | ||
| Z-0519-04 | LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-Preterm Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway. | Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative. | Terminated | ||
| Z-0518-04 | LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-Standard Child w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in Compact Case; 860055-Pediatric Complete in Display Case; 860056-Standard Term-Baby w/Infant Mask 0-1 in Carton; 865500-Pediatric Upgrade Kit . Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway. | Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative. | Terminated | ||
| Z-0517-04 | LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway. | Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain