Nonin Medical, Inc
Plymouth, MN, US
NONIN MEDICAL, INC. appears in FDA device records in Plymouth, MN. FDA records list 50 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 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 50 510(k) clearances for Nonin Medical, Inc between 1986 and 2024. The busiest year on record is 2005, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1994 | 2 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 4 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | OLK | Substantially Equivalent | |
| K192900 | H500 Multi-Sensing Oximetry System | DQA | Substantially Equivalent | |
| K191403 | Pulse Oximeter | DQA | Substantially Equivalent | |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | MUD | Substantially Equivalent | |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | DQA | Substantially Equivalent | |
| K160231 | Model X-100C CO-Met™ Oximetry System | DQA | Substantially Equivalent | |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | DQA | Substantially Equivalent | |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | MUD | Substantially Equivalent | |
| K140785 | PULSE OXIMETER | DQA | Substantially Equivalent | |
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | DQA | Substantially Equivalent | |
| K131021 | PULSE OXIMETER | DQA | Substantially Equivalent | |
| K113215 | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY | MUD | Substantially Equivalent | |
| K112843 | PULSE OXIMETER | DQA | Substantially Equivalent | |
| K102350 | PULSE OXIMETER | DQA | Substantially Equivalent | |
| K102715 | REGIONAL OXIMETER | MUD | Substantially Equivalent | |
| K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | DQA | Substantially Equivalent | |
| K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR | DQA | Substantially Equivalent | |
| K092101 | REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES | DQA | Substantially Equivalent | |
| K092678 | EVISION DATA MANAGEMENT SOFTWARE | DQA | Substantially Equivalent | |
| K090807 | REGIONAL OXIMETER SYSTEM, MODEL 7600 | MUD | Substantially Equivalent | |
| K081285 | FINGER PULSE OXIMETER, MODEL 9560 | DQA | Substantially Equivalent | |
| K080255 | NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER | DQA | Substantially Equivalent | |
| K071415 | DIGITAL PULSE OXIMETER, MODEL 7500FO | DQA | Substantially Equivalent | |
| K071285 | DIGITAL PULSE OXIMETER, MODEL 7500 | DQA | Substantially Equivalent | |
| K063752 | LIFESENSE, MODEL LS1-9R | DQA | Substantially Equivalent | |
| K053130 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 | DQA | Substantially Equivalent | |
| K052669 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 | DQA | Substantially Equivalent | |
| K052829 | WRISTOX MODEL 3100 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K050056 | MODEL 2500A PALMSAT PULSE OXIMETER | DQA | Substantially Equivalent | |
| K051107 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 | DQA | Substantially Equivalent | |
| K043359 | 4100 PATIENT OXIMETER MODULE | DQA | Substantially Equivalent | |
| K041156 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 | DQA | Substantially Equivalent | |
| K040589 | MODIFICATION TO AVANT 9600 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K033307 | NVISION DATA MANAGEMENT SOFTWARE | DQA | Substantially Equivalent | |
| K031487 | MODEL AVANT 2120 PULSE OXIMETER AND NIBP | DXN | Substantially Equivalent | |
| K030668 | MODEL 3100 WRISTOX PULSE OXIMETER | DQA | Substantially Equivalent | |
| K023044 | MODEL 9600, AVANT PULSE OXIMETER | DQA | Substantially Equivalent | |
| K013319 | NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR | DQA | Substantially Equivalent | |
| K002690 | MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 | DQA | Substantially Equivalent | |
| K001930 | MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 | DQA | Substantially Equivalent | |
| K001085 | MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 | DQA | Substantially Equivalent | |
| K982969 | NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 | CCK | Substantially Equivalent | |
| K945290 | 8500A PULSE OXIMETER | DQA | Substantially Equivalent | |
| K942248 | MINIATURIZED FINGER CLIP PULSE OXIMETER | DQA | Substantially Equivalent | |
| K940463 | NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS | DQA | Substantially Equivalent | |
| K910001 | MODEL 8604-FO PULSE OXIMETER | DQA | Substantially Equivalent | |
| K893221 | MODEL 8500 HAND HELD PULSE OXIMETER | DQA | Substantially Equivalent | |
| K890033 | MODEL 8700 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K874947 | MODEL 8800 CARDIORESPIRATORY OXIMETER | DQA | Substantially Equivalent | |
| K860051 | MODEL 8604 OXYGEN/PULSE MONITOR | DQA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183646 | 2183646 | NONIN MEDICAL, INC. | 13700 1ST AVE, NORTH, Plymouth, MN 55441 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1690-2017 | 8500M Handheld Pulse Oximeter | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature. | Class II | Terminated | |
| Z-0901-2015 | SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box. | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported. | Class II | Terminated | |
| Z-0458-2010 | Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA. | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient. | Terminated | ||
| Z-0843-2008 | Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA | Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain