Data / Medical devices / United States / Nonin Medical, Inc.
Nonin Medical, Inc.: FDA-registered device maker in Plymouth, MN, United States, 31 510(k) clearances
Nonin Medical, Inc. is registered with the FDA (registration 2183646) in Plymouth, MN, United States. It lists 7 device types. The FDA files 31 510(k) clearances under its listings, the newest dated June 29, 2020. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2183646
- Address
- 13700 1ST Ave, North, Plymouth, MN, United States, 55441
- Owner or operator
- NONIN MEDICAL, INC. (2183646)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 15, 2006
- Registered through
- 2026
- Brand names listed
- 2500, 2500A, 2500B, 2500C, 3231, 7600PA, 8000FC Sensor, 8000FI Sensor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter, Ear | DPZ | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 29, 2020 | K192900 | H500 Multi-Sensing Oximetry System | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| December 20, 2019 | K191403 | Pulse Oximeter | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| May 2, 2019 | K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | MUD | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| August 5, 2016 | 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 | Nonin Medical, Inc. | accessdata.fda.gov |
| August 27, 2015 | K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | MUD | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| July 7, 2014 | K140785 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| February 21, 2014 | K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| September 11, 2013 | K131021 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| April 19, 2012 | K112843 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| December 22, 2010 | K102350 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 4, 2010 | K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| March 4, 2010 | K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| October 21, 2009 | K092101 | REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| October 1, 2009 | K092678 | EVISION DATA MANAGEMENT SOFTWARE | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 30, 2009 | K090807 | REGIONAL OXIMETER SYSTEM, MODEL 7600 | MUD | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 5, 2008 | K081285 | FINGER PULSE OXIMETER, MODEL 9560 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| May 23, 2008 | K080255 | NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| August 8, 2007 | K071415 | DIGITAL PULSE OXIMETER, MODEL 7500FO | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| July 12, 2007 | K071285 | DIGITAL PULSE OXIMETER, MODEL 7500 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| May 4, 2007 | K063752 | LIFESENSE, MODEL LS1-9R | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 21, 2005 | K050056 | MODEL 2500A PALMSAT PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 1, 2005 | K051107 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| January 7, 2005 | K043359 | 4100 PATIENT OXIMETER MODULE | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 9, 2004 | K041156 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| June 3, 2004 | K040589 | MODIFICATION TO AVANT 9600 PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| July 23, 2003 | K023044 | MODEL 9600, AVANT PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| January 3, 2002 | K013319 | NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| October 11, 2000 | K002690 | MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| August 12, 1999 | K982969 | NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 | CCK | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| December 8, 1994 | K942248 | MINIATURIZED FINGER CLIP PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| February 28, 1990 | K893221 | MODEL 8500 HAND HELD PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 29, 2016 | 75424 | Class II | Terminated | 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. | accessdata.fda.gov |
| November 25, 2014 | 70045 | Class II | Terminated | 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 manua | 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. | accessdata.fda.gov |
| October 23, 2009 | 53801 | Not yet classified | Terminated | 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 5544 | 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. | accessdata.fda.gov |
| October 11, 2007 | 45812 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Oximeter, Tissue Saturation
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter, Wellness
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Medical Device Data System
Updated June 29, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.