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

NLF — Predicate Candidate Screening

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

154 daysmedian FDA review time

437 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241758	Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reproce	Stryker Sustainability Solutions	2024-10-22	124	0
K222019	Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reproce	Stryker Sustainability Solutions	2022-12-04	149	0
K211138	Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse	Stryker Sustainability Solutions	2022-03-08	326	0
K201699	Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor	Surgical Instrument and Savings Inc (Dba Medline Renewal)	2020-07-22	30	0
K191018	Medline ReNewal Reprocessed Masimo LNCS Series Adult and Ped	Surgical Instrument Service and Savings, Inc.	2019-07-03	77	0
K111773	RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, I	Renu Medical, Inc.	2011-11-16	146	0
K110723	M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS	Masimo Corporation	2011-07-28	134	0
K102560	REPROCESSED PULSE OXIMETER SENSORS	Sterilmed, Inc.	2011-02-18	164	0
K101280	MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PR	Midwest Reprocessing Center, LLC	2010-10-07	154	0
K092368	REPROCESSED PULSE OXIMETER SENSORS	Sterilmed, Inc.	2009-11-03	90	0
K083719	LNCS OXIMETRY SENSORS	Masimo Corporation	2009-07-30	227	0
K081927	RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO	Renu Medical, Inc.	2009-02-06	214	0
K081238	REPROCESSED MASIMO PULSE OXIMETER SENSORS	Ascent Healthcare Solutions	2008-07-29	89	0
K080424	HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1	Hygia Health Services, Inc.	2008-05-28	103	0
K072194	RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25	Renu Medical, Inc.	2007-11-29	114	0
K063661	RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20	Renu Medical, Inc.	2007-05-25	168	0
K042891	DATEX-OHMEDA OXY-AFR SENSOR	Datex-Ohmeda	2005-06-29	253	0
K042316	VANGUARD REPROCESSED PULSE OXIMETER SENSORS	Vanguard Medical Concepts, Inc.	2005-01-06	133	0
K033973	OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR	Nellcor Puritan Bennett, Inc.	2004-12-13	357	0
K041127	MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS	Sterilmed, Inc.	2004-09-23	146	0
K041867	HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS	Hygia Health Services, Inc.	2004-09-10	63	0
K012715	HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II	Hygia Health Services, Inc.	2003-08-01	717	0
K012677	REPROCESSED PULSE OXIMETER SENSORS	Sterilmed, Inc.	2003-03-28	591	0
K012344	VANGUARD REPROCESSED PULSE OXIMETER SENSORS	Vanguard Medical Concepts, Inc.	2002-10-04	437	3
K012600	CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L	Clearmedical, Inc.	2002-07-03	324	0
K012609	CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-2	Clearmedical, Inc.	2002-07-03	324	0
K012622	CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20	Clearmedical, Inc.	2002-07-03	324	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