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

Y — Predicate Candidate Screening

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

61 daysmedian FDA review time

208 days90th percentile

78clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K955846	MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS II	Y	1996-10-01	280	0
K960280	IVAC NEEDLE FREE VALVE ADMINISTRATION SETS	Y	1996-04-04	76	4
K953225	IVAC BALL VALCE ADMIN. SETS	Y	1995-09-27	79	0
K934095	IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS	Y	1994-08-10	352	0
K940897	IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET	Y	1994-06-22	118	0
K931550	EZ ADMINISTRATION SET	Y	1994-01-10	287	1
K932544	IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599	Y	1993-10-12	139	0
K922115	IVAC NEEDLELESS INJECTION VALVE	Y	1993-10-12	525	0
K931549	MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP	Y	1993-10-12	197	1
K930781	INFUSION PUMP	Y	1993-08-19	184	0
K925228	IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL	Y	1993-07-30	287	0
K925091	IVAC SYRING PUMP MODEL 770	Y	1993-07-08	274	0
K923981	IVAC SYRINGE PUMP - 740 SERIES	Y	1993-01-15	161	0
K915063	IVAC PC ANIFUSER	Y	1992-06-03	208	0
K901550	IVAC(R) SYRINGE PUMP - MODEL 770	Y	1990-10-04	184	0
K903879	IVAC(R) SYRINGE PUMP - MODEL 740	Y	1990-10-03	42	0
K896914	IVAC MODEL 2090 INFRA RED THERMOMETER	Y	1990-03-02	81	0
K894487	IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+	Y	1989-09-27	71	0
K894037	IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599	Y	1989-08-28	83	0
K891583	IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES	Y	1989-06-09	81	0
K883986	CRIS ADAPTER	Y	1989-02-24	157	0
K884307	IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262	Y	1988-11-01	19	0
K882302	IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080	Y	1988-07-12	40	2
K875332	IVAC VOLUMETRIC PUMP - MODEL 590	Y	1988-05-20	142	0
K874481	IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290	Y	1988-03-03	122	0
K874491	IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+	Y	1988-02-25	115	0
K874581	IVAC(R) DUAL RATE ADAPTER - MODEL 70090	Y	1988-01-19	71	0
K873884	IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP	Y	1988-01-06	105	0
K873938	IVAC(R) DUAL RATE SET - MODEL C50066	Y	1987-12-11	74	0
K873776	IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+	Y	1987-12-03	78	0
K872764	IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053	Y	1987-11-03	113	1
K870317	IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280	Y	1987-04-03	65	0
K864809	IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580	Y	1987-02-10	63	0
K870132	IVAC FLOW CONTROL ADMINISTRATION SET	Y	1987-02-05	24	0
K864164	CRIS ADAPTED WITH VOLUME LIMITING BAG	Y	1986-12-16	54	0
K853664	HEPARIN MICRO-INFUSOR	Y	1986-03-18	196	0
K852168	ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY	Y	1986-03-12	296	0
K860436	IVAC MODEL 2080 ELECTRONIC THERMOMETER	Y	1986-02-12	8	0
K854574	IVAC CONTROLLED RELEASE INFUSION SYSTEM	Y	1986-01-23	79	0
K852488	CONTROLLED RELEASE INFUSION SYSTEM(CRIS)	Y	1985-06-27	20	0
K851447	IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP	Y	1985-05-08	44	0
K844843	IVAC DRUG ADMINISTRATION DEVICE	Y	1985-04-09	117	0
K850182	IVAC KEOFEED II POLYURETHANE FEEDING TUBE	Y	1985-03-19	60	0
K844937	IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI	Y	1985-01-25	37	0
K843185	IVAC C80014 Y SOLUTION ADMIN. SET	Y	1984-09-20	38	0
K842589	IVAC KEOFEED HYDROPHILIC FEEDING TUBE	Y	1984-08-14	42	0
K842419	IVAC 280 VOLUMETRIC INFUSION CONTROLLER	Y	1984-08-07	48	0
K842027	IVAC 3080 ENTERAL FEEDING PUMP	Y	1984-07-18	61	0
K833034	UNIVERSAL VENTED & NON/VOLUME INFUS-	Y	1983-11-07	61	0
K833033	INFUSION SET-52-05-1 20 DROPS-MI VOL	Y	1983-11-07	61	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