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

Jelco Laboratories — Predicate Candidate Screening

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

39 daysmedian FDA review time

76 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K791918	JELCO WINGED INTRAVASCULAR CATHETER	Jelco Laboratories	1979-10-02	7
K791372	JELCO & KVO CATHETER PLACEMENT UNIT	Jelco Laboratories	1979-09-12	50
K790967	CATHETER METAL HUB/RADIOPAQUE	Jelco Laboratories	1979-06-27	36
K790968	CATHETER METAL HUB/NONRADIOPAQUE	Jelco Laboratories	1979-06-11	20
K790471	JELCO* DISC FILTER-0.2 MICRON	Jelco Laboratories	1979-04-30	56
K790186	PROTECTIVSTABILIZER	Jelco Laboratories	1979-02-26	28
K790079	NEEDLE, BLOOD COLLECTING	Jelco Laboratories	1979-02-01	23
K790107	CATHETER TUBING MODIFICATION	Jelco Laboratories	1979-02-01	16
K781857	TRAY, ARTERIAL BLOOD GAS SAMPLING	Jelco Laboratories	1978-12-11	35
K780896	NEEDLES, DESIGN CHANGE, IV CATHETERS	Jelco Laboratories	1978-08-23	85
K780519	FILTER TUBE	Jelco Laboratories	1978-05-09	39
K771874	J-VAC VACUUM TUBE	Jelco Laboratories	1977-12-02	60
K771536	AIR VENT FILTER NEEDLE, 0.45	Jelco Laboratories	1977-10-25	76
K771827	INTRAVENOUS FILTER W/FLASH BULB	Jelco Laboratories	1977-10-13	24
K771381	IV CATHETER HUB	Jelco Laboratories	1977-10-13	79
K771826	INTRAVENOUS FILTER W/AUTO AIR VENT	Jelco Laboratories	1977-10-13	24
K771551	I.V. PREP & CARE KIT	Jelco Laboratories	1977-10-04	53
K770589	FILTER, INTRAVENOUS W/AUTO AIR VENT	Jelco Laboratories	1977-05-23	56
K770119	I.V. LOK TM	Jelco Laboratories	1977-03-14	52
K760319	KIT, CATHETER	Jelco Laboratories	1976-08-11	16
K760022	NEEDLE, FILTER	Jelco Laboratories	1976-08-09	56
K760019	VACUUM TUBES, PEDIATRIC SIZES (J-VAC)	Jelco Laboratories	1976-07-20	39
K760018	VACUUM TUBES, STERILE (J-VAC)	Jelco Laboratories	1976-07-20	39
K760103	CAP, INJECTION (#4600)	Jelco Laboratories	1976-07-16	23
K760110	FILTER, I.V. (#4700)	Jelco Laboratories	1976-07-16	22
K760111	FILTER, I.V., WITH FLASH BULB (#4701)	Jelco Laboratories	1976-07-16	22

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