# Nonin Medical, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 50 (1986–2024): 50 510(k) clearances
- Product codes: DQA (42), MUD (5), DXN (1), OLK (1), CCK (1)
- 510(k) review time since 2016: median 231 days, against 202 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 71 (53 its own); citations of its devices by later devices: 105 (53 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Masimo Corporation: 3 (https://510kreport.com/company/masimo)
- Cas Medical Systems, Inc.: 3 (https://510kreport.com/company/cas-medical-systems)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Somanetics Corp.: 2 (https://510kreport.com/company/somanetics)
- Oridion Medical 1987, Ltd.: 1 (https://510kreport.com/company/oridion-medical-1987)
- Bci Intl., Inc.: 1 (https://510kreport.com/company/bci-intl)
- Nellcor, Inc.: 1 (https://510kreport.com/company/nellcor)
- Spegas Industries, Ltd.: 1 (https://510kreport.com/company/spegas-industries)

## Firms that cite its devices most
- Cas Medical Systems, Inc.: 5 (https://510kreport.com/company/cas-medical-systems)
- Taiwan Aulisa Medical Devices Technologies, Inc.: 3 (https://510kreport.com/company/taiwan-aulisa-medical-devices-technologies)
- Beijing Choice Electronic Technololgy Co., Ltd.: 3 (https://510kreport.com/company/beijing-choice-electronic-technololgy)
- Mediaid, Inc.: 3 (https://510kreport.com/company/mediaid)
- S.P.O. Medical Equipment, Ltd.: 2 (https://510kreport.com/company/spo-medical-equipment)
- Marquette Medical Systems, Inc.: 2 (https://510kreport.com/company/marquette-medical-systems)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Shenzhen Envisen Industry Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-envisen-industry)

## Its most-cited devices
- K050056: Model 2500A Palmsat Pulse Oximeter (2005), cited by 8
- K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 (2000), cited by 7
- K102715: Regional Oximeter (2010), cited by 6
- K040589: Modification to Avant 9600 Pulse Oximeter (2004), cited by 5
- K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter (2008), cited by 5
- K051107: Onyx II Finger Pulse Oximeter, Model 9550 (2005), cited by 4

## Recent decisions
- K211498: Nonin OTC Pulse Oximeter Model 3250 (Nov 13, 2024)
- K192900: H500 Multi-Sensing Oximetry System (Jun 29, 2020)
- K191403: Pulse Oximeter (Dec 20, 2019)
- K190560: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface (May 2, 2019)
- K172625: Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (May 11, 2018)
- K160231: Model X-100C CO-Met™ Oximetry System (Dec 23, 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 (Aug 5, 2016)
- K151305: SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) (Aug 27, 2015)

Source page: https://510kreport.com/company/nonin-medical