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

GBS — Predicate Candidate Screening

27 FDA 510(k) clearances under this product code; the 50 most recent screened below.

28 daysmedian FDA review time

88 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K912645	ATRIUMS PDR THORACIC CATHETER	Atrium Medical Corp.	1991-09-13	88	17
K883887	AXIOM ATRAUM WOUND DRAINS	Axiom, Inc.	1989-02-17	157	0
K881873	INTRODUCTION/DRAINAGE CATHETER & ACCESS	Sheridan Catheter Corp.	1988-05-18	15	0
K880895	URESIL WOUND DRAIN TROCAR	Uresil Corp.	1988-03-14	12	0
K880376	NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP	Genesis Industries, Inc.	1988-02-16	20	0
K873377	CLOSED CHEST DRAINAGE SET W/SUTURES	Gish Biomedical, Inc.	1987-10-28	65	0
K872460	AN3000 MAHONEY DRAIN	H.W. Andersen Products, Inc.	1987-07-23	30	0
K872459	AN3100 MULHOLLAND DRAIN	H.W. Andersen Products, Inc.	1987-07-21	28	0
K872457	AN3500 WORTH DRAIN	H.W. Andersen Products, Inc.	1987-07-21	28	0
K870015	HCI ALL PURPOSE DRAIN/CATHETER SET	Health Care Innovations, Inc.	1987-02-06	35	0
K863560	URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA	Uresil Corp.	1986-09-29	17	0
K863142	THORACIC CATHETER (CHEST DRAINAGE TUBE)	Sheridan Catheter Corp.	1986-08-29	14	0
K863247	AXIOM TROCAR THORACIC CATHETER	Axiom Medical, Inc.	1986-08-29	7	0
K862584	OSTEOTOMY DRAINAGE TUBE	Treace Medical, Inc.	1986-08-12	36	0
K862767	SILICONE SUMP DRAIN	Sil-Med Corp.	1986-08-07	16	0
K854418	ROUND SUCTION DRAIN	Sil-Med Corp.	1985-11-19	15	0
K853131	THORO/CATH STRAIGHT THORACIC RIGHT ANGLE	J. H. Emerson Co.	1985-09-05	41	0
K852241	AXIOM ATRAUM TROCAR CATHETER	Axiom Medical, Inc.	1985-06-14	22	0
K851048	CHEST CATHETERS/THORACIC CATHETERS	Medovations, Inc.	1985-06-05	83	0
K843906	SNYDER HEMOVAC WOUND DRAINAGE DEVICES	Snyder Laboratories, Inc.	1984-11-05	33	0
K832416	AXIOM HYDROMER WOUND DRAINS	Axiom Medical, Inc.	1983-10-31	102	0
K822318	ARGYLE MEDIASTINAL DRAIN	Sherwood Medical Co.	1982-08-27	24	0
K813463	SIL-V-UR CHEST CATHETER	C.R. Bard, Inc.	1982-02-12	63	0
K813587	DISPOSABLE THORACIC CATHETER	Texas Medical Products, Inc.	1982-01-12	15	0
K810158	DAVOL SILICONE SHEATH SUMP DRAIN	C.R. Bard, Inc.	1981-02-13	23	0
K810071	STERILE SILICONE TUBING	Medspec Corp.	1981-02-12	30	0
K802318	ARGYLE SILICONE THORACIC CATHETER	Sherwood Medical Co.	1980-10-23	30	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