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

Concord Laboratories, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time

101 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K883840	DRI-VENT ARTERIAL BLOOD SAMPLING KIT	Concord Laboratories, Inc.	1989-05-16	246
K871825	MECONIUM SUCTION CATHETER	Concord Laboratories, Inc.	1987-06-29	49
K864535	TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110	Concord Laboratories, Inc.	1987-01-06	50
K862039	CONCORD CARE TRAY	Concord Laboratories, Inc.	1986-07-03	36
K854601	SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH	Concord Laboratories, Inc.	1986-01-10	53
K854327	SUBCUTANEOUS TUNNELING NEEDLES & HANDLES	Concord Laboratories, Inc.	1985-11-13	16
K851134	REGIONAL ANESTHESIA TRAYS	Concord Laboratories, Inc.	1985-07-15	116
K842095	EPIDURAL TRAYS	Concord Laboratories, Inc.	1984-07-03	39
K841486	ARTERIAL BLOOD SAMPLING KITS	Concord Laboratories, Inc.	1984-05-23	43
K840986	PREFILLED PULSATOR SYRINGE	Concord Laboratories, Inc.	1984-04-05	29
K840987	VAPORIZED HEPARIN	Concord Laboratories, Inc.	1984-04-05	29
K840709	MID-STREAM URINE COLLECTION SETS	Concord Laboratories, Inc.	1984-04-03	46
K833814	SANI CATCH BA	Concord Laboratories, Inc.	1984-03-19	138
K840988	NO POUR BASIN	Concord Laboratories, Inc.	1984-03-07	0
K833993	ALCOHOL SWABS	Concord Laboratories, Inc.	1984-01-30	70
K833936	ACETONE ALCOHOL SWABS	Concord Laboratories, Inc.	1984-01-30	76
K833582	PULSATOR ARTERIAL BLOOD SAMPLING SYRIN	Concord Laboratories, Inc.	1983-12-27	76
K832778	EPIDURAL SYRINGE	Concord Laboratories, Inc.	1983-09-26	41
K811009	PREFILLED PULSATOR SYRINGE	Concord Laboratories, Inc.	1981-06-12	58
K810995	PREFILLED PULSATOR SYRINGE	Concord Laboratories, Inc.	1981-05-21	38
K801814	CATHETER SUCTION TRACHEOBRONCHIAL	Concord Laboratories, Inc.	1980-08-14	15
K782090	CLAMP, DISPOSABLE	Concord Laboratories, Inc.	1978-12-20	6
K780419	SUBCLAVIAN TRAY	Concord Laboratories, Inc.	1978-03-27	13
K772218	CATHETER, SILICONE COATED	Concord Laboratories, Inc.	1977-12-13	11
K771667	BLOOD GAS TRAY #4024	Concord Laboratories, Inc.	1977-10-13	43
K771673	CATHETEO CARE TRAY #0242	Concord Laboratories, Inc.	1977-09-30	28
K770850	TRAY, BLOOD GAS, ARTERIAL, #4014	Concord Laboratories, Inc.	1977-07-15	67
K770851	SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016	Concord Laboratories, Inc.	1977-07-14	66
K770852	SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015	Concord Laboratories, Inc.	1977-07-14	66
K771103	URETHRAL TRAY W/CATHETER, 7750	Concord Laboratories, Inc.	1977-06-24	4
K771104	URETHRAL TRAY W/OUT CAHTETER, 7650	Concord Laboratories, Inc.	1977-06-24	4
K770673	COLLECTOR, SANI-CATCH, NO. 1014	Concord Laboratories, Inc.	1977-04-15	7
K770672	COLLECTOR, SANI-CATCH, NO. 1010	Concord Laboratories, Inc.	1977-04-15	7
K770361	TRAY, BLOOD GAS, CAT. NO. 4010	Concord Laboratories, Inc.	1977-04-05	42
K770557	DRAINAGE BAG, 4000 ML.	Concord Laboratories, Inc.	1977-03-24	3
K770496	UNIVERSAL TRAY	Concord Laboratories, Inc.	1977-03-21	7
K770497	DRAINAGE UNIT, COMBINATION	Concord Laboratories, Inc.	1977-03-21	7
K760127	TRAY, CATHETERIZATION W/O CATHETER	Concord Laboratories, Inc.	1976-10-07	101
K760105	BAG, URINE COLLECTION, CLOSED SYSTEM	Concord Laboratories, Inc.	1976-10-07	105
K760128	TRAY, CATHETERIZATION W/ CATHETER	Concord Laboratories, Inc.	1976-10-07	101
K760085	BASIN, STERILE (#3200)	Concord Laboratories, Inc.	1976-07-20	29
K760086	TRAY, BLOOD SAMPLING (PULSATOR II)	Concord Laboratories, Inc.	1976-07-16	25

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