Nonin Medical, Inc
FDA Regulatory Profile
Nonin Medical, Inc appears in FDA public data with 2 recalls, 50 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1690-2017, Class II) was initiated on September 29, 2016. Its most recent 510(k) clearance was granted on November 13, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 50
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1690-2017 | Class II | 8500M Handheld Pulse Oximeter | September 29, 2016 |
| Z-0901-2015 | Class II | SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (R | November 25, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | November 13, 2024 |
| K192900 | H500 Multi-Sensing Oximetry System | June 29, 2020 |
| K191403 | Pulse Oximeter | December 20, 2019 |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient In | May 2, 2019 |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | May 11, 2018 |
| K160231 | Model X-100C CO-Met Oximetry System | December 23, 2016 |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100 | August 5, 2016 |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Region | August 27, 2015 |
| K140785 | PULSE OXIMETER | July 7, 2014 |
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | February 21, 2014 |
| K131021 | PULSE OXIMETER | September 11, 2013 |
| K113215 | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY | May 14, 2012 |
| K112843 | PULSE OXIMETER | April 19, 2012 |
| K102350 | PULSE OXIMETER | December 22, 2010 |
| K102715 | REGIONAL OXIMETER | December 17, 2010 |
| K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | June 4, 2010 |
| K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR | March 4, 2010 |
| K092101 | REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES | October 21, 2009 |
| K092678 | EVISION DATA MANAGEMENT SOFTWARE | October 1, 2009 |
| K090807 | REGIONAL OXIMETER SYSTEM, MODEL 7600 | June 30, 2009 |