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

Philips Medical Systems — Predicate Candidate Screening

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

60 daysmedian FDA review time

206 days90th percentile

107clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212704	Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti	Philips Medical Systems	2021-09-24	29	0
K211597	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Di	Philips Medical Systems	2021-09-08	107	0
K210560	Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph,	Philips Medical Systems	2021-06-30	125	0
K191738	PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, Pa	Philips Medical Systems	2020-09-29	459	0
K192875	Philips Biosensor BX100	Philips Medical Systems	2020-04-16	191	0
K183387	M3290B Patient Information Center iX	Philips Medical Systems	2019-08-06	243	0
K180017	MX40 Release C.01	Philips Medical Systems	2018-07-24	203	0
K172226	MX40 Release B.07	Philips Medical Systems	2017-11-09	107	0
K163584	M3290B Philips IntelliVue Information Center iX	Philips Medical Systems	2017-07-07	199	0
K163649	SureSigns VS3; SureSigns VS4	Philips Medical Systems	2017-03-31	98	0
K161164	CareEvent inclusive of the CareEvent Mobile Application acce	Philips Medical Systems	2016-06-24	60	3
K153702	M3290B Philips IntelliVue Information Center iX	Philips Medical Systems	2016-06-13	173	9
K160951	Philips Efficia CMS200 Central Monitoring System	Philips Medical Systems	2016-05-05	30	0
K151812	PATIENT MONITORS VARIOUS MODELS	Philips Medical Systems	2016-01-26	208	0
K151366	Philips CS770 IntelliSpace Critical Care and Anesthesia	Philips Medical Systems	2015-10-30	162	0
K152363	Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra	Philips Medical Systems	2015-10-27	68	0
K133659	HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DI	Philips Medical Systems	2015-01-23	422	0
K142935	CareEvent	Philips Medical Systems	2015-01-15	98	0
K143057	M3290B Philips IntelliVue Information Center iX	Philips Medical Systems	2014-12-03	40	0
K133603	PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION	Philips Medical Systems	2014-09-25	304	0
K133961	SURESIGNS VS3, SURESIGNS VS4	Philips Medical Systems	2014-06-26	184	0
K132524	CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING A	Philips Medical Systems	2014-06-13	305	1
K131590	INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE	Philips Medical Systems	2013-10-23	145	0
K130684	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	Philips Medical Systems	2013-10-18	219	1
K132068	PHILIPS DXL 12/16-LEAD ECG ALGORITHM	Philips Medical Systems	2013-09-26	85	0
K131032	PHILIPS SURESIGNS CENTRAL	Philips Medical Systems	2013-08-12	122	0
K123900	SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8	Philips Medical Systems	2013-04-18	121	0
K130153	HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST	Philips Medical Systems	2013-03-12	49	0
K120815	INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE	Philips Medical Systems	2013-03-06	352	0
K123492	DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)	Philips Medical Systems	2012-12-13	30	0
K113144	PAGEWRITER TC 20, 30, 50, 70	Philips Medical Systems	2012-04-03	161	0
K110825	PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES,	Philips Medical Systems	2012-02-16	330	6
K120132	SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS	Philips Medical Systems	2012-02-14	28	0
K113125	INTELLIVUE MX40 PATIENT MONITOR	Philips Medical Systems	2011-11-17	24	2
K111693	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	Philips Medical Systems	2011-10-28	134	1
K112652	SURESIGNS VS2+ -SURESIGNS VSI	Philips Medical Systems	2011-10-11	29	3
K110572	MAMMODIAGNOST DR	Philips Medical Systems	2011-09-23	206	0
K111114	SURESIGNS VS2 VITAL SIGNS MONITOR	Philips Medical Systems	2011-05-20	29	0
K110803	SURESIGNS VSI VITAL SIGNS MONITOR	Philips Medical Systems	2011-05-20	58	0
K110287	PHILIPS ECG LEADWIRE SET	Philips Medical Systems	2011-02-15	15	0
K102974	INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00	Philips Medical Systems	2011-01-04	90	0
K102495	M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0	Philips Medical Systems	2010-09-30	30	6
K101521	ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O	Philips Medical Systems	2010-07-29	57	0
K101067	SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 8	Philips Medical Systems	2010-05-07	21	1
K100272	INTELLIVUE CLINICAL INFORMATION PORTFOLIO	Philips Medical Systems	2010-04-14	75	2
K093177	INTELLIBRIDGE SYSTEM	Philips Medical Systems	2009-12-18	71	0
K091176	PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441	Philips Medical Systems	2009-11-13	205	0
K090483	SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS	Philips Medical Systems	2009-03-20	23	3
K083413	COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM	Philips Medical Systems	2008-12-18	30	0
K081983	M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00	Philips Medical Systems	2008-08-22	42	3

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