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

Hewlett-Packard Co. — Predicate Candidate Screening

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

81 daysmedian FDA review time

235 days90th percentile

230clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K992543	HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGE	Hewlett-Packard Co.	2000-05-18	293	0
K993587	HP M2376A DEVICE LINK SYSTEM	Hewlett-Packard Co.	2000-01-20	90	0
K993169	MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIV	Hewlett-Packard Co.	1999-12-20	89	0
K992977	HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODE	Hewlett-Packard Co.	1999-12-01	89	0
K993516	HP M2600A VIRIDIA TELEMETRY SYSTEM	Hewlett-Packard Co.	1999-11-08	21	0
K993171	HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A	Hewlett-Packard Co.	1999-10-21	30	0
K992636	HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A	Hewlett-Packard Co.	1999-08-31	25	8
K991871	HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL	Hewlett-Packard Co.	1999-08-05	65	0
K984194	HP M2376A DEVICE LINK SYSTEM	Hewlett-Packard Co.	1999-04-30	158	0
K990400	LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IM	Hewlett-Packard Co.	1999-02-24	15	0
K990339	SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O	Hewlett-Packard Co.	1999-02-18	15	1
K981376	HEWLETT-PACKARD M1205A VIRIDIA 24 CT	Hewlett-Packard Co.	1999-01-04	263	0
K984286	HEARTSTREAM ELECTRODE ADAPTER	Hewlett-Packard Co.	1998-12-17	16	0
K980429	HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP	Hewlett-Packard Co.	1998-09-09	217	0
K982025	HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER	Hewlett-Packard Co.	1998-09-04	87	0
K982619	HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02	Hewlett-Packard Co.	1998-08-12	16	0
K974457	SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ	Hewlett-Packard Co.	1998-07-14	231	0
K981265	PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH A	Hewlett-Packard Co.	1998-06-23	77	0
K974087	MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT	Hewlett-Packard Co.	1998-06-15	229	0
K980687	SONOS 5500 ULTRASOUND IMAGING SYSTEM	Hewlett-Packard Co.	1998-05-22	88	0
K974746	M1765A ECG MANAGER	Hewlett-Packard Co.	1998-03-18	89	0
K974420	M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1	Hewlett-Packard Co.	1998-02-19	87	0
K974567	HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER	Hewlett-Packard Co.	1998-01-20	46	0
K971116	SONOS 5500 IMAGING SYSTEM	Hewlett-Packard Co.	1998-01-12	292	0
K972348	HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND S	Hewlett-Packard Co.	1997-07-24	30	1
K964832	HEWLETT-PACKARD CENTRALVUE SOFTWARE	Hewlett-Packard Co.	1997-05-15	164	0
K964309	SONOS 2000, SONOS 2500 (M2406 A)	Hewlett-Packard Co.	1997-04-22	175	0
K963706	PHILIPS SONO DIAGNOST 800	Hewlett-Packard Co.	1997-03-19	184	0
K970034	SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM	Hewlett-Packard Co.	1997-03-17	73	0
K964122	HP STAR ST AND ARRHHYTHMIA SOFTWARE	Hewlett-Packard Co.	1997-01-08	85	0
K961165	HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A	Hewlett-Packard Co.	1996-10-10	199	0
K961401	HP CATHSTATION - MODEL M1264B	Hewlett-Packard Co.	1996-10-08	180	0
K954028	HP SONOS ULTRASOUND IMAGING SYSTEM	Hewlett-Packard Co.	1996-08-08	346	2
K961009	STRESSWRITER EXERCISE TESTING SYSTEM	Hewlett-Packard Co.	1996-06-17	97	0
K960934	HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24	Hewlett-Packard Co.	1996-06-14	98	0
K954980	PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO	Hewlett-Packard Co.	1996-05-15	197	0
K954957	CODEMASTER XL + XL W/SHOCK ADVISORY OPTION	Hewlett-Packard Co.	1996-05-07	193	0
K955327	HP SONOS 100CF ULTRASOUND IMAGING SYSTEM	Hewlett-Packard Co.	1996-04-08	140	0
K952540	SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)	Hewlett-Packard Co.	1996-03-11	293	0
K953127	ACCUSTRESS EXERCISE TESTING SYSTEM	Hewlett-Packard Co.	1996-02-29	239	0
K951978	HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INS	Hewlett-Packard Co.	1996-01-04	252	0
K954668	HP ECHO IMAGE MANAGEMENT SYSTEM	Hewlett-Packard Co.	1995-11-22	43	0
K950821	HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MOD	Hewlett-Packard Co.	1995-10-03	222	0
K952173	HEWLETT-PACKARD MODEL M1264B CATHSTATION	Hewlett-Packard Co.	1995-08-11	95	0
K941282	ECG FAX MODEM	Hewlett-Packard Co.	1995-05-26	441	0
K950483	HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR	Hewlett-Packard Co.	1995-05-22	108	0
K943389	SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTE	Hewlett-Packard Co.	1995-03-17	246	0
K944048	ULTRASOUND 77030 IMAGING SYSTEM	Hewlett-Packard Co.	1995-03-01	195	0
K945277	HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICA	Hewlett-Packard Co.	1995-01-30	94	0
K935923	PHILIPS ULTRASOUND P800 IMAGING SYSTEM	Hewlett-Packard Co.	1994-12-08	360	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