Product Code: KDQ FDA class 2 21 CFR 880.6740

Bottle, Collection, Vacuum

General Hospital

A vacuum collection bottle is a sealed container connected to a hospital suction system to collect aspirated fluids, secretions, or wound exudate from patients, used alongside vacuum regulators and suction tubing in clinical drainage applications. It is classified as an FDA Class 2 device, indicating moderate risk, and requires premarket clearance. Product code KDQ is regulated under 21 CFR 880.6740 in the General Hospital medical specialty. No additional special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

276

Registration Numbers

276

Unique Applicants

Years Active

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Basic Information

Product Code: KDQ
Device Class: FDA class 2
Regulation Number: 880.6740
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K081718	EXPRESS CHEST DRAIN	Jul 25, 2008	Substantially Equivalent	Atrium Medical Corp.
K062302	MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM	Oct 06, 2006	Substantially Equivalent	Millicore AB
K043582	OCEAN CHEST DRAIN	Jan 21, 2005	Substantially Equivalent	Atrium Medical Corp.
K984496	ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN	May 05, 1999	Substantially Equivalent	Atrium Medical Corp.
K962856	PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR	Aug 28, 1996	Substantially Equivalent	Deknatel, Inc.
K961287	ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM	Jul 26, 1996	Substantially Equivalent	Rocket Medical Plc
K962168	MUCUS SPECIMEN TRAP	Jul 22, 1996	Substantially Equivalent	Sage Products, Inc.
K950677	ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN	Apr 13, 1995	Substantially Equivalent	Atrium Medical Corp.
K941818	PM9000 VAC TRAP	Dec 12, 1994	Substantially Equivalent	Precision Medical, Inc.
K932327	THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM	Jul 13, 1993	Substantially Equivalent	Davol, Inc.
K912704	ATRIUM 2000 CHEST DRAIN	Aug 26, 1991	Substantially Equivalent	Atrium Medical Corp.
K905768	PLEUR-EVAC CHEST DRAINAGE SYSTEMS	Feb 11, 1991	Substantially Equivalent	Deknatel, Inc.
K897125	ATRIUM 2000, CHEST DRAIN	Mar 30, 1990	Substantially Equivalent	Atrium Medical Corp.
K896697	PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI	Feb 08, 1990	Substantially Equivalent	Deknatel, Inc.
K896127	THORA-KLEX CHEST DRAINAGE UNIT	Jan 24, 1990	Substantially Equivalent	Davol, Inc.
K892915	PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION	Jun 21, 1989	Substantially Equivalent	Deknatel, Inc.
K882468	ELIMINATOR AIR FILTER	Aug 29, 1988	Substantially Equivalent	Apex Medical, Inc.
K882223	PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST	Aug 16, 1988	Substantially Equivalent	Deknatel, Inc.
K881149	MUCUS TRAP OR SUCTION TRAP	Jun 14, 1988	Substantially Equivalent	Ferguson Medical
K863561	URESIL THORACIC VENT	Sep 23, 1986	Substantially Equivalent	Uresil Corp.
K861025	T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES	Apr 28, 1986	Substantially Equivalent	Boehringer Laboratories
K855074	FILTERED VACUUM SAFETY TRAP BOTTLE	Mar 13, 1986	Substantially Equivalent	Boehringer Laboratories
K854359	LM2000A SURGICAL SUCTION MONITOR	Mar 03, 1986	Substantially Equivalent	Engineering, Inc.
K860023	COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT	Jan 10, 1986	Substantially Equivalent	Atrium Medical Corp.
K854634	BARD PARKER THORACIC VENT	Dec 27, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K844853	NIFA NON INVASIVE FLUTTER ASSEMBLY	Dec 12, 1985	Substantially Equivalent	Emergency Management Products, Inc.
K851244	GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO	Nov 19, 1985	Substantially Equivalent	Cook, Inc.
K851892	COMPACT 2000	Jun 14, 1985	Substantially Equivalent	Atrium Medical Corp.
K851316	ABCO SUCTION CANISTER	May 08, 1985	Substantially Equivalent	Abco Dealers, Inc.
K844942	PLURA-GARD CHEST DRAINAGE SYSTEM	Mar 12, 1985	Substantially Equivalent	Consolidated Medical Equipment, Inc.
K830671	THORAX-KLEX CHEST DRAINAGE UNIT	Mar 29, 1983	Substantially Equivalent	C.R. Bard, Inc.
K812746	THORACIC DRAINAGE SET #55-DB2-G	Oct 26, 1981	Substantially Equivalent	J. H. Emerson Co.
K812224	PLEURAL DRAINAGE SYSTEM #PDS-4300	Sep 09, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K812139	VACUUM SUCTION FILTER	Aug 20, 1981	Substantially Equivalent	K & G Healthcare Ind., Inc.
K811437	MODIFIED THORACENTESIS CATHETER	Aug 13, 1981	Substantially Equivalent	Blair Medical Products
K811955	CALIBRATED BREATHING SYSTEM COLLECTION	Aug 04, 1981	Substantially Equivalent	Anchor Brush Co., Inc.
K811192	VAC-RITE SUNCTION COLLECTION	Jun 02, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K810574	SUCTION COLLECTION BOTTLE, DISPOSABLE	Apr 21, 1981	Substantially Equivalent	Harvard Laboratories
K810892	ELECTRO-SUCTION UNIT	Apr 17, 1981	Substantially Equivalent	Jedmed Instrument Co.
K802174	ARGYLE SUCTION CANISTER W/DISP. LINER	Sep 26, 1980	Substantially Equivalent	Sherwood Medical Co.
K801221	THORA-DRAIN III PLASTIC DRAINAGE SYSTEM	Jun 09, 1980	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K800861	SNYDER HEMOVAC CHEST DRAINAGE SOLUTION	May 02, 1980	Substantially Equivalent	Snyder Laboratories, Inc.
K791254	CONPHAR SILICONE DRAINS-STERILE	Aug 03, 1979	Substantially Equivalent	Conphar, Inc.
K790379	SEP-T-VAC SUCTION CANNISTER W/ TUBING	Apr 10, 1979	Substantially Equivalent	Sherwood Medical Co.
K781279	SUCTION CANISTER	Aug 10, 1978	Substantially Equivalent	Abco Dealers, Inc.
K781234	TUBES, LUKENS, TOMAS	Aug 10, 1978	Substantially Equivalent	Ludwig Medical, Inc.
K770649	VAC-RITE	Jun 02, 1977	Substantially Equivalent	Medical Development Co.
K761202	AQUA-SEAL	Dec 09, 1976	Substantially Equivalent	Respiratory Care, Inc.