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

KDQ — Predicate Candidate Screening

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

46 daysmedian FDA review time

125 days90th percentile

48clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K081718	EXPRESS CHEST DRAIN	Atrium Medical Corp.	2008-07-25	37	4
K062302	MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM	Millicore AB	2006-10-06	59	0
K043582	OCEAN CHEST DRAIN	Atrium Medical Corp.	2005-01-21	24	17
K984496	ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN	Atrium Medical Corp.	1999-05-05	139	0
K962856	PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODE	Deknatel, Inc.	1996-08-28	37	1
K961287	ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM	Rocket Medical Plc	1996-07-26	114	0
K962168	MUCUS SPECIMEN TRAP	Sage Products, Inc.	1996-07-22	47	0
K950677	ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN	Atrium Medical Corp.	1995-04-13	58	0
K941818	PM9000 VAC TRAP	Precision Medical, Inc.	1994-12-12	243	0
K932327	THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM	Davol, Inc.	1993-07-13	61	0
K912704	ATRIUM 2000 CHEST DRAIN	Atrium Medical Corp.	1991-08-26	68	0
K905768	PLEUR-EVAC CHEST DRAINAGE SYSTEMS	Deknatel, Inc.	1991-02-11	46	0
K897125	ATRIUM 2000, CHEST DRAIN	Atrium Medical Corp.	1990-03-30	94	0
K896697	PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI	Deknatel, Inc.	1990-02-08	72	0
K896127	THORA-KLEX CHEST DRAINAGE UNIT	Davol, Inc.	1990-01-24	93	0
K892915	PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION	Deknatel, Inc.	1989-06-21	62	0
K882468	ELIMINATOR AIR FILTER	Apex Medical, Inc.	1988-08-29	75	0
K882223	PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST	Deknatel, Inc.	1988-08-16	82	0
K881149	MUCUS TRAP OR SUCTION TRAP	Ferguson Medical	1988-06-14	89	0
K863561	URESIL THORACIC VENT	Uresil Corp.	1986-09-23	11	0
K861025	T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES	Boehringer Laboratories	1986-04-28	41	0
K855074	FILTERED VACUUM SAFETY TRAP BOTTLE	Boehringer Laboratories	1986-03-13	84	0
K854359	LM2000A SURGICAL SUCTION MONITOR	Engineering, Inc.	1986-03-03	125	0
K860023	COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT	Atrium Medical Corp.	1986-01-10	7	0
K854634	BARD PARKER THORACIC VENT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-12-27	38	0
K844853	NIFA NON INVASIVE FLUTTER ASSEMBLY	Emergency Management Products, Inc.	1985-12-12	363	0
K851244	GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO	Cook, Inc.	1985-11-19	266	0
K851892	COMPACT 2000	Atrium Medical Corp.	1985-06-14	45	0
K851316	ABCO SUCTION CANISTER	Abco Dealers, Inc.	1985-05-08	36	0
K844942	PLURA-GARD CHEST DRAINAGE SYSTEM	Consolidated Medical Equipment, Inc.	1985-03-12	82	0
K830671	THORAX-KLEX CHEST DRAINAGE UNIT	C.R. Bard, Inc.	1983-03-29	25	0
K812746	THORACIC DRAINAGE SET #55-DB2-G	J. H. Emerson Co.	1981-10-26	27	0
K812224	PLEURAL DRAINAGE SYSTEM #PDS-4300	Bentley Laboratories, Inc.	1981-09-09	30	0
K812139	VACUUM SUCTION FILTER	K & G Healthcare Ind., Inc.	1981-08-20	23	0
K811437	MODIFIED THORACENTESIS CATHETER	Blair Medical Products	1981-08-13	83	0
K811955	CALIBRATED BREATHING SYSTEM COLLECTION	Anchor Brush Co., Inc.	1981-08-04	34	0
K811192	VAC-RITE SUNCTION COLLECTION	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-06-02	33	0
K810574	SUCTION COLLECTION BOTTLE, DISPOSABLE	Harvard Laboratories	1981-04-21	49	0
K810892	ELECTRO-SUCTION UNIT	Jedmed Instrument Co.	1981-04-17	15	0
K802174	ARGYLE SUCTION CANISTER W/DISP. LINER	Sherwood Medical Co.	1980-09-26	17	0
K801221	THORA-DRAIN III PLASTIC DRAINAGE SYSTEM	Chesebrough-Pond'S U.S.A. Co.	1980-06-09	18	0
K800861	SNYDER HEMOVAC CHEST DRAINAGE SOLUTION	Snyder Laboratories, Inc.	1980-05-02	16	0
K791254	CONPHAR SILICONE DRAINS-STERILE	Conphar, Inc.	1979-08-03	28	0
K790379	SEP-T-VAC SUCTION CANNISTER W/ TUBING	Sherwood Medical Co.	1979-04-10	46	0
K781234	TUBES, LUKENS, TOMAS	Ludwig Medical, Inc.	1978-08-10	22	0
K781279	SUCTION CANISTER	Abco Dealers, Inc.	1978-08-10	15	0
K770649	VAC-RITE	Medical Development Co.	1977-06-02	57	0
K761202	AQUA-SEAL	Respiratory Care, Inc.	1976-12-09	2	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