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

GCY — Predicate Candidate Screening

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

36 daysmedian FDA review time

129 days90th percentile

96clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972703	REDYROB-CLOSED WOUND DRAINAGE SYSTEM	B.Braun Medical, Inc.	1997-10-01	75	0
K971036	ODONTIT AUTOGENOUS BONE COLLECTION DEVICE	Interpore Intl.	1997-06-03	75	0
K963839	CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500	Cordis Corp.	1996-12-12	79	0
K960099	PENROSE DRAIN MODELS 6001 - 6007	Sil-Med Corp.	1996-03-11	60	0
K950754	MACRO SUCTION TUBE MODEL NO 10061	Dlp, Inc.	1995-04-25	67	0
K936223	PRESSURE IRRIGATING SYSTEM	Level 1 Technologies, Inc.	1994-05-12	134	0
K930615	AUTOVAC CLOSED WOUND SUCTION SYSTEM	Boehringer Laboratories	1994-02-22	382	0
K933319	BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE	Birtcher Medical Systems, Inc.	1993-10-27	112	0
K933305	IMC 5.0MM IRRIGATION/ASPIRATION PROBE	Inman Medical Corp.	1993-10-05	90	0
K933306	IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES	Inman Medical Corp.	1993-10-05	90	0
K933170	INMAN POOLE TIP SUCTION PROBE W/TUBING KIT	Inman Medical Corp.	1993-09-16	79	0
K931950	POOLE TIP SUCTION PROBE	Mayaguez Medical Center	1993-08-11	113	0
K931856	5.0 MM IRRIGATION/ASPIRATION PROBE	Mayaguez Medical Center	1993-08-10	119	0
K925024	ORC TAPPERED IRRIGATING PROBE	O.R. Concepts, Inc.	1993-05-21	231	0
K923908	# 9455 AND #9457 POOLE TIP SUCTION PROBE	O.R. Concepts, Inc.	1993-05-17	286	0
K920819	ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN	Astra Meditec AB	1993-03-24	394	0
K925989	KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR	Kendall Healthcare Products Co. Div.Of Tyco Health	1993-02-26	93	0
K925749	KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML	Kendall Healthcare Products Co. Div.Of Tyco Health	1993-02-01	80	0
K922895	J-VAC BULB SUCTION RESERVOIR	Johnson & Johnson Medical, Inc.	1992-09-15	91	0
K915867	SOLCOVAC WOUND DRAINAGE SYSTEM	Solco Basle, Inc.	1992-08-14	227	0
K915536	DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC	Davol, Inc.	1992-03-26	107	0
K910167	MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM	Microbio-Medics, Inc.	1991-04-15	90	0
K905733	SEROMA-CATH CLOSE DRAINAGE SYSTEM	Dawn Medical	1991-01-28	35	0
K901742	INAMED SMALL DRAIN SYSTEM	Inamed Development Co.	1990-05-07	20	0
K901764	INAMED CONVERTIBLE DRAIN SYSTEM	Inamed Development Co.	1990-05-07	19	0
K896491	INAMED CLOSED-WOUND DRAIN SYSTEM	Inamed Development Co.	1990-01-08	56	0
K896803	CLOSED WOUND RESERVOIR	Westmark, Sterile Packing Systems, Inc. (Sps)	1989-12-27	26	0
K883982	DRENOVAC	Iberhospitex, S.A.	1989-02-23	156	0
K883472	CLOSED WOUND SUCTION DEVICE	Westmark, Sterile Packing Systems, Inc. (Sps)	1988-10-18	63	0
K883433	AMBU TWIN PUMP - (MANUAL SUCTION PUMP)	Ambu, Inc.	1988-09-02	18	0
K881036	HEMO SUC NUMBER HS100-HS205	Instrumental Medico Croquevielle S.A.	1988-06-20	102	0
K881012	WOUND-EVAC RS	Heritage Medical Products	1988-03-17	7	0
K880650	HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS	Baxter Healthcare Corp	1988-02-24	7	0
K874645	CLOSED WOUND DRAINAGE SYSTEMS	Hall Laboratories, Inc.	1987-12-02	19	0
K873332	MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM	American V. Mueller	1987-09-08	20	0
K863482	DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE	Cardio Metrics, Inc.	1986-10-14	35	0
K863562	URESIL 150CC BELLOWS RESERVOIR	Uresil Corp.	1986-09-29	17	0
K863505	URESIL CLOSED DRAINAGE RESERVOIR	Uresil Corp.	1986-09-18	9	0
K863201	NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC	Allergan, Inc.	1986-08-29	10	0
K860981	ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM	Sun Technologies	1986-05-02	49	0
K854424	BARD PARKER 150CC BELLOWS RESERVOIR	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-11-20	15	0
K853295	EMODREN EXCHANGEABLE PLASTIC BELLOWS	Parexel Intl. Corp.	1985-08-20	14	0
K850634	SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS	Surgidyne, Inc.	1985-06-28	129	0
K851084	ECONOMY 400 CWS WITH PVC DRAINS	C.R. Bard, Inc.	1985-06-04	78	0
K850011	PROVAC WOUND HEALING/SUCTION SET	Medical Matrix, Inc.	1985-05-21	139	0
K850037	CLOSED WOUND DRAIN	Consolidated Medical Equipment, Inc.	1985-03-19	71	0
K844921	PERIMETER CLOSED WOUND RESEVOIR	Perimeter Medical, Inc.	1985-03-18	89	0
K842710	CONCEPT C-VAC	Concept, Inc.	1984-10-31	111	0
K840913	PROVAC WOUND DRAINAGE & HEALING SYS	Meyer Medical U.S.A., Inc.	1984-04-24	55	0
K833586	TLS BULB DRAINAGE SYSTEM	Porex Medical	1984-01-30	110	2

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