Nonin Medical, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
50
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1690-2017Class II8500M Handheld Pulse OximeterSeptember 29, 2016
Z-0901-2015Class IISenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (RNovember 25, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K211498Nonin OTC Pulse Oximeter Model 3250November 13, 2024
K192900H500 Multi-Sensing Oximetry SystemJune 29, 2020
K191403Pulse OximeterDecember 20, 2019
K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InMay 2, 2019
K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorMay 11, 2018
K160231Model X-100C CO-Met™ Oximetry SystemDecember 23, 2016
K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100August 5, 2016
K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA RegionAugust 27, 2015
K140785PULSE OXIMETERJuly 7, 2014
K132402SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEMFebruary 21, 2014
K131021PULSE OXIMETERSeptember 11, 2013
K113215MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGYMay 14, 2012
K112843PULSE OXIMETERApril 19, 2012
K102350PULSE OXIMETERDecember 22, 2010
K102715REGIONAL OXIMETERDecember 17, 2010
K093853SINGLE-PATIENT USE DISPOSABLE SENSOR SERIESJune 4, 2010
K093306SINGLE-PATIENT USE DISPOSABLE SENSORMarch 4, 2010
K092101REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIESOctober 21, 2009
K092678EVISION DATA MANAGEMENT SOFTWAREOctober 1, 2009
K090807REGIONAL OXIMETER SYSTEM, MODEL 7600June 30, 2009