Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nonin Medical, Inc. · Predicate Candidate Screening

50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

125 daysmedian FDA review time

315 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211498	Nonin OTC Pulse Oximeter Model 3250	Nonin Medical, Inc.	2024-11-13	1279	0
K192900	H500 Multi-Sensing Oximetry System	Nonin Medical, Inc.	2020-06-29	258	0
K191403	Pulse Oximeter	Nonin Medical, Inc.	2019-12-20	210	0
K190560	SenSmart Model 8006CA Reusable Regional Oximetry Sensor, Sen	Nonin Medical, Inc.	2019-05-02	58	0
K172625	Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor	Nonin Medical, Inc.	2018-05-11	252	0
K160231	Model X-100C CO-Met™ Oximetry System	Nonin Medical, Inc.	2016-12-23	326	0
K160865	Model 6100C Series Single-Patient Use, Disposable Pulse Oxim	Nonin Medical, Inc.	2016-08-05	128	0
K151305	SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediat	Nonin Medical, Inc.	2015-08-27	101	0
K140785	PULSE OXIMETER	Nonin Medical, Inc.	2014-07-07	98	0
K132402	SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM	Nonin Medical, Inc.	2014-02-21	204	1
K131021	PULSE OXIMETER	Nonin Medical, Inc.	2013-09-11	152	0
K113215	MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY	Nonin Medical, Inc.	2012-05-14	195	0
K112843	PULSE OXIMETER	Nonin Medical, Inc.	2012-04-19	203	0
K102350	PULSE OXIMETER	Nonin Medical, Inc.	2010-12-22	125	0
K102715	REGIONAL OXIMETER	Nonin Medical, Inc.	2010-12-17	88	0
K093853	SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES	Nonin Medical, Inc.	2010-06-04	170	0
K093306	SINGLE-PATIENT USE DISPOSABLE SENSOR	Nonin Medical, Inc.	2010-03-04	133	0
K092101	REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES	Nonin Medical, Inc.	2009-10-21	99	0
K092678	EVISION DATA MANAGEMENT SOFTWARE	Nonin Medical, Inc.	2009-10-01	30	0
K090807	REGIONAL OXIMETER SYSTEM, MODEL 7600	Nonin Medical, Inc.	2009-06-30	97	1
K081285	FINGER PULSE OXIMETER, MODEL 9560	Nonin Medical, Inc.	2008-06-05	30	0
K080255	NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER	Nonin Medical, Inc.	2008-05-23	113	0
K071415	DIGITAL PULSE OXIMETER, MODEL 7500FO	Nonin Medical, Inc.	2007-08-08	79	0
K071285	DIGITAL PULSE OXIMETER, MODEL 7500	Nonin Medical, Inc.	2007-07-12	66	0
K063752	LIFESENSE, MODEL LS1-9R	Nonin Medical, Inc.	2007-05-04	136	0
K053130	ONYX II FINGER PULSE OXIMETER, MODEL 9550	Nonin Medical, Inc.	2006-01-11	64	0
K052669	AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100	Nonin Medical, Inc.	2005-12-23	87	0
K052829	WRISTOX MODEL 3100 PULSE OXIMETER	Nonin Medical, Inc.	2005-11-10	36	0
K050056	MODEL 2500A PALMSAT PULSE OXIMETER	Nonin Medical, Inc.	2005-06-21	161	1
K051107	ONYX II FINGER PULSE OXIMETER, MODEL 9550	Nonin Medical, Inc.	2005-06-01	30	0
K043359	4100 PATIENT OXIMETER MODULE	Nonin Medical, Inc.	2005-01-07	32	0
K041156	AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001	Nonin Medical, Inc.	2004-06-09	37	1
K040589	MODIFICATION TO AVANT 9600 PULSE OXIMETER	Nonin Medical, Inc.	2004-06-03	87	0
K033307	NVISION DATA MANAGEMENT SOFTWARE	Nonin Medical, Inc.	2004-05-06	205	0
K031487	MODEL AVANT 2120 PULSE OXIMETER AND NIBP	Nonin Medical, Inc.	2004-03-22	315	0
K030668	MODEL 3100 WRISTOX PULSE OXIMETER	Nonin Medical, Inc.	2003-10-17	228	0
K023044	MODEL 9600, AVANT PULSE OXIMETER	Nonin Medical, Inc.	2003-07-23	314	0
K013319	NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSU	Nonin Medical, Inc.	2002-01-03	90	0
K002690	MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500	Nonin Medical, Inc.	2000-10-11	43	2
K001930	MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500	Nonin Medical, Inc.	2000-07-20	24	0
K001085	MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500	Nonin Medical, Inc.	2000-05-01	27	0
K982969	NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 984	Nonin Medical, Inc.	1999-08-12	352	0
K945290	8500A PULSE OXIMETER	Nonin Medical, Inc.	1997-02-11	834	0
K942248	MINIATURIZED FINGER CLIP PULSE OXIMETER	Nonin Medical, Inc.	1994-12-08	213	0
K940463	NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS	Nonin Medical, Inc.	1994-03-14	40	0
K910001	MODEL 8604-FO PULSE OXIMETER	Nonin Medical, Inc.	1991-07-18	197	0
K893221	MODEL 8500 HAND HELD PULSE OXIMETER	Nonin Medical, Inc.	1990-02-28	307	0
K890033	MODEL 8700 PULSE OXIMETER	Nonin Medical, Inc.	1989-02-06	33	0
K874947	MODEL 8800 CARDIORESPIRATORY OXIMETER	Nonin Medical, Inc.	1988-02-12	72	0
K860051	MODEL 8604 OXYGEN/PULSE MONITOR	Nonin Medical, Inc.	1986-06-05	150	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda