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

Philips Medical Systems North America Co. · Predicate Candidate Screening

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

58 daysmedian FDA review time

92 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K101311	EP NAVIGATOR R3	Philips Medical Systems North America Co.	2010-09-30	142	0
K090625	WIRELESS PORTABLE DETECTOR FD-W17	Philips Medical Systems North America Co.	2009-03-24	15	28
K090590	VERADIUS, MODEL 718-130	Philips Medical Systems North America Co.	2009-03-16	12	0
K082280	SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MON	Philips Medical Systems North America Co.	2008-10-08	58	0
K063781	PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE	Philips Medical Systems North America Co.	2007-01-05	15	1
K062268	MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREM	Philips Medical Systems North America Co.	2006-10-18	72	0
K061685	PULSERA	Philips Medical Systems North America Co.	2006-09-15	92	0
K061995	XCELERA	Philips Medical Systems North America Co.	2006-09-06	54	0
K060749	XPERCT	Philips Medical Systems North America Co.	2006-04-04	15	0
K050692	FLXIS	Philips Medical Systems North America Co.	2005-04-08	22	0
K043147	ACHIEVA FAMILY	Philips Medical Systems North America Co.	2005-02-15	92	13
K042368	PRACTIX CONVENIO	Philips Medical Systems North America Co.	2004-10-04	34	4
K042334	ALLURA 3D-CA, RELEASE 1	Philips Medical Systems North America Co.	2004-09-27	28	0
K041949	ALLURA XPER FD10	Philips Medical Systems North America Co.	2004-07-30	10	33
K040254	INTEGRIS 3D-RA, RELEASE 4.2	Philips Medical Systems North America Co.	2004-02-19	15	0
K031836	PHILIPS FRESCO RELEASE 1	Philips Medical Systems North America Co.	2003-08-14	62	0
K031597	DUNLEE FORMAT COLLIMATOR FAMILY	Philips Medical Systems North America Co.	2003-07-21	61	0
K031535	PHILIPS EASYDIAGNOST ELEVA	Philips Medical Systems North America Co.	2003-06-17	32	13
K030520	INTERA FAMILY	Philips Medical Systems North America Co.	2003-03-06	15	11
K023137	PHILIPS EASYVISION WORKSTATION RELEASE 6	Philips Medical Systems North America Co.	2002-12-19	90	0
K022899	PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0	Philips Medical Systems North America Co.	2002-11-22	80	8
K022788	PHILIPS HARMONY RELEASE 1	Philips Medical Systems North America Co.	2002-10-25	64	2
K013344	INTERA I/T	Philips Medical Systems North America Co.	2001-12-11	63	2
K012238	DOSERIGHT	Philips Medical Systems North America Co.	2001-10-01	76	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