Company · US
Nonin Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2024. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 2024 | K211498 | Nonin OTC Pulse Oximeter Model 3250 Nonin Medical, Inc. | OLK |
| Jun 29, 2020 | K192900 | H500 Multi-Sensing Oximetry System Nonin Medical, Inc. | DQA |
| Dec 20, 2019 | K191403 | Pulse Oximeter Nonin Medical, Inc. | DQA |
| May 2, 2019 | K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface Nonin Medical, Inc. | MUD |
| May 11, 2018 | K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor Nonin Medical, Inc. | DQA |
| Dec 23, 2016 | K160231 | Model X-100C CO-Met Oximetry System Nonin Medical, Inc. | DQA |
| Aug 5, 2016 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Nonin Medical, Inc. | DQA |
| Aug 27, 2015 | K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor ( Nonin Medical, Inc. | MUD |
| Jul 7, 2014 | K140785 | PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Feb 21, 2014 | K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM Nonin Medical, Inc. | DQA |
| Sep 11, 2013 | K131021 | PULSE OXIMETER Nonin Medical, Inc. | DQA |
| May 14, 2012 | K113215 | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY Nonin Medical, Inc. | MUD |
| Apr 19, 2012 | K112843 | PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Dec 22, 2010 | K102350 | PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Dec 17, 2010 | K102715 | REGIONAL OXIMETER Nonin Medical, Inc. | MUD |
| Jun 4, 2010 | K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES Nonin Medical, Inc. | DQA |
| Mar 4, 2010 | K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR Nonin Medical, Inc. | DQA |
| Oct 21, 2009 | K092101 | REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES Nonin Medical, Inc. | DQA |
| Oct 1, 2009 | K092678 | EVISION DATA MANAGEMENT SOFTWARE Nonin Medical, Inc. | DQA |
| Jun 30, 2009 | K090807 | REGIONAL OXIMETER SYSTEM, MODEL 7600 Nonin Medical, Inc. | MUD |
| Jun 5, 2008 | K081285 | FINGER PULSE OXIMETER, MODEL 9560 Nonin Medical, Inc. | DQA |
| May 23, 2008 | K080255 | NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Aug 8, 2007 | K071415 | DIGITAL PULSE OXIMETER, MODEL 7500FO Nonin Medical, Inc. | DQA |
| Jul 12, 2007 | K071285 | DIGITAL PULSE OXIMETER, MODEL 7500 Nonin Medical, Inc. | DQA |
| May 4, 2007 | K063752 | LIFESENSE, MODEL LS1-9R Nonin Medical, Inc. | DQA |
| Jan 11, 2006 | K053130 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 Nonin Medical, Inc. | DQA |
| Dec 23, 2005 | K052669 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 Nonin Medical, Inc. | DQA |
| Nov 10, 2005 | K052829 | WRISTOX MODEL 3100 PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Jun 21, 2005 | K050056 | MODEL 2500A PALMSAT PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Jun 1, 2005 | K051107 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 Nonin Medical, Inc. | DQA |
| Jan 7, 2005 | K043359 | 4100 PATIENT OXIMETER MODULE Nonin Medical, Inc. | DQA |
| Jun 9, 2004 | K041156 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 Nonin Medical, Inc. | DQA |
| Jun 3, 2004 | K040589 | MODIFICATION TO AVANT 9600 PULSE OXIMETER Nonin Medical, Inc. | DQA |
| May 6, 2004 | K033307 | NVISION DATA MANAGEMENT SOFTWARE Nonin Medical, Inc. | DQA |
| Mar 22, 2004 | K031487 | MODEL AVANT 2120 PULSE OXIMETER AND NIBP Nonin Medical, Inc. | DXN |
| Oct 17, 2003 | K030668 | MODEL 3100 WRISTOX PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Jul 23, 2003 | K023044 | MODEL 9600, AVANT PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Jan 3, 2002 | K013319 | NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR Nonin Medical, Inc. | DQA |
| Oct 11, 2000 | K002690 | MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 Nonin Medical, Inc. | DQA |
| Jul 20, 2000 | K001930 | MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 Nonin Medical, Inc. | DQA |
| May 1, 2000 | K001085 | MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 Nonin Medical, Inc. | DQA |
| Aug 12, 1999 | K982969 | NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 Nonin Medical, Inc. | CCK |
| Feb 11, 1997 | K945290 | 8500A PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Dec 8, 1994 | K942248 | MINIATURIZED FINGER CLIP PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Mar 14, 1994 | K940463 | NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS Nonin Medical, Inc. | DQA |
| Jul 18, 1991 | K910001 | MODEL 8604-FO PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Feb 28, 1990 | K893221 | MODEL 8500 HAND HELD PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Feb 6, 1989 | K890033 | MODEL 8700 PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Feb 12, 1988 | K874947 | MODEL 8800 CARDIORESPIRATORY OXIMETER Nonin Medical, Inc. | DQA |
| Jun 5, 1986 | K860051 | MODEL 8604 OXYGEN/PULSE MONITOR Nonin Medical, Inc. | DQA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2016 | Nonin Medical, Inc 8500M Handheld Pulse Oximeter Terminated |
DQA | K893221 |
| Dec 31, 2014 | Nonin Medical, Inc 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 Terminated |
DQA | K132402 |
| Nov 25, 2009 | Nonin Medical, Inc 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, Pl Terminated |
MUD | K090807 |
| Apr 11, 2008 | Nonin Medical, Inc Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA Terminated |
DQA | K002690 K050056 |