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

Imed Corp. — Predicate Candidate Screening

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

78 daysmedian FDA review time

241 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960512	GEMINI PC-ITX	Imed Corp.	1996-11-21	290	0
K953896	THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS	Imed Corp.	1996-03-20	216	1
K950153	VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE	Imed Corp.	1995-08-24	219	0
K951922	ADMINISTRATION SETS WITH BALL FLOAT	Imed Corp.	1995-07-19	86	0
K950419	THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS	Imed Corp.	1995-06-21	141	11
K944320	VENTED/NON-VENTED GEMINI ADMINISTRATION SET	Imed Corp.	1995-02-14	169	5
K945070	VERSASAE PLASTIC CANNULA- 11 GAUGE	Imed Corp.	1995-01-13	91	0
K931173	PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH	Imed Corp.	1994-04-15	403	0
K933144	GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER	Imed Corp.	1993-10-12	106	0
K924718	SHROUDED NEEDLE DEVICES	Imed Corp.	1993-06-18	270	0
K921378	IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE	Imed Corp.	1992-06-09	78	0
K913658	IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD	Imed Corp.	1992-03-26	241	1
K895797	IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE	Imed Corp.	1990-01-02	96	1
K894842	IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM	Imed Corp.	1989-09-12	43	1
K883993	MODIFIED IMED GEMINI PC-1 INFUSION PUMP	Imed Corp.	1988-12-19	90	0
K880479	IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP	Imed Corp.	1988-04-25	80	0
K872952	ULTRASONIC AIR-IN-LINE DETECTOR (AILD)	Imed Corp.	1987-10-20	84	0
K870656	IMED(R) 980C VOLUMETRIC INFUSION PUMP	Imed Corp.	1987-10-20	244	0
K870991	IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP	Imed Corp.	1987-06-04	85	0
K870992	IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP	Imed Corp.	1987-06-04	85	0
K862295	MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER	Imed Corp.	1986-09-23	98	1
K851360	IMED GRAVISET INTRAVASCULAR ADMIN. SET	Imed Corp.	1985-05-08	34	0
K850653	IMED 440 INFUSION PUMP & ADMINISTRATION SET	Imed Corp.	1985-04-09	49	0
K844915	IMED 980 VOLUMETRIC INFUSION PUMP	Imed Corp.	1985-03-06	78	0
K831935	ENTERNAL PUMP & ADMIN. SET 430	Imed Corp.	1983-08-08	54	0
K831596	DROP RATE COUNTER #340	Imed Corp.	1983-07-12	56	0
K823346	ACCUSET ADMINISTRATION SET	Imed Corp.	1982-11-30	21	0
K823347	MACRODOT ADD-I-MED ADMIN. SET	Imed Corp.	1982-11-24	15	0
K823026	380 PIGGYBACK CONTROLLER	Imed Corp.	1982-11-22	39	0
K823027	ACCUDOT 380 SECONDARY I.V. SET	Imed Corp.	1982-11-22	39	0
K820451	INTRODUCER FOR ENDOTRACHEAL TUBE	Imed Corp.	1982-03-26	36	0
K813446	IV FILTERSET 0.22 MICROMETER	Imed Corp.	1982-01-05	27	0
K813445	IV FILTERSET 5 MICROMETER	Imed Corp.	1982-01-05	27	0
K812823	IMED MODEL 970 & 975 VOL. INFUSION PUMP	Imed Corp.	1981-10-27	19	0
K812824	PRESSURE DISC COMPONENT FOR ACCUSET	Imed Corp.	1981-10-27	19	0
K812035	IMED ACCUSET CASSETTE	Imed Corp.	1981-07-28	8	0
K801734	IMED DROP RATE CALCULATOR #340	Imed Corp.	1980-10-23	90	0
K790669	DROP CONTROLLER	Imed Corp.	1979-05-14	38	0
K790108	FILTERSET 0.22, I.V. PUMP	Imed Corp.	1979-03-06	49	0
K781589	VOLUMETRIC CONTROLLER MODEL 310	Imed Corp.	1978-11-22	65	0
K781171	INFUSION PUMP, PEDIATRIC MODEL 301	Imed Corp.	1978-08-10	28	0
K771664	VOLUMETRIC INFUSION PUMP MODEL 960	Imed Corp.	1977-09-12	12	0
K771453	FLUID HANDLING DEVICE W/INPUT TUBING	Imed Corp.	1977-08-22	19	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