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

Masimo Corp. — Predicate Candidate Screening

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

30 daysmedian FDA review time

128 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K041815	LNCS OXIMETRY SENSORS	Masimo Corp.	2004-07-29	23	0
K041204	NC SP02 ADAPTER CABLE	Masimo Corp.	2004-06-29	53	0
K040259	MASIMO SET INTELLIVUE PULSE OXIMETER MODULE	Masimo Corp.	2004-04-22	78	0
K033998	MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V	Masimo Corp.	2004-03-19	86	0
K040214	MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATS	Masimo Corp.	2004-02-25	26	0
K032551	MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR	Masimo Corp.	2004-02-19	184	0
K033296	MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD	Masimo Corp.	2004-02-19	128	1
K033349	AC-1 SP02 ADAPTOR CABLE, MODEL AC-1	Masimo Corp.	2004-01-28	100	0
K033298	SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS	Masimo Corp.	2003-12-12	59	0
K031330	MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSH	Masimo Corp.	2003-05-12	14	0
K013792	MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSH	Masimo Corp.	2001-12-11	27	0
K012992	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO S	Masimo Corp.	2001-10-03	27	0
K011851	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SER	Masimo Corp.	2001-07-11	28	0
K010419	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SER	Masimo Corp.	2001-03-06	22	0
K003167	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SER	Masimo Corp.	2000-11-08	29	0
K003244	MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSH	Masimo Corp.	2000-11-08	22	0
K002939	MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSH	Masimo Corp.	2000-10-06	15	0
K002751	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SER	Masimo Corp.	2000-10-05	30	0
K002682	MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSH	Masimo Corp.	2000-09-13	16	0
K002477	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SER	Masimo Corp.	2000-09-08	28	0
K002574	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SER	Masimo Corp.	2000-09-06	19	0
K000126	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP	Masimo Corp.	2000-04-14	87	0
K993555	MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES	Masimo Corp.	1999-11-19	30	0
K992238	MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-	Masimo Corp.	1999-10-08	98	0
K992340	MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP	Masimo Corp.	1999-10-08	87	1
K990966	MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIA	Masimo Corp.	1999-06-07	76	0
K973887	MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSO	Masimo Corp.	1998-01-08	86	0
K962603	MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS	Masimo Corp.	1997-02-06	219	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