Atlas FDA

KDQ

48 FDA 510(k) clearances · Product code

46 daysmedian time to decision
125 days90th percentile
48clearances measured

FDA profile

Official device name
Bottle, Collection, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 110 · 2022: 118 · 2023: 92 · 2024: 172 · 2025: 95 · 2026: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EXPRESS CHEST DRAIN (K081718)Atrium Medical Corp.2008-07-25
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (K062302)Millicore AB2006-10-06
OCEAN CHEST DRAIN (K043582)Atrium Medical Corp.2005-01-21
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (K984496)Atrium Medical Corp.1999-05-05
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR (K962856)Deknatel, Inc.1996-08-28
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (K961287)Rocket Medical Plc1996-07-26
MUCUS SPECIMEN TRAP (K962168)Sage Products, Inc.1996-07-22
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (K950677)Atrium Medical Corp.1995-04-13
PM9000 VAC TRAP (K941818)Precision Medical, Inc.1994-12-12
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (K932327)Davol, Inc.1993-07-13
ATRIUM 2000 CHEST DRAIN (K912704)Atrium Medical Corp.1991-08-26
PLEUR-EVAC CHEST DRAINAGE SYSTEMS (K905768)Deknatel, Inc.1991-02-11
ATRIUM 2000, CHEST DRAIN (K897125)Atrium Medical Corp.1990-03-30
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI (K896697)Deknatel, Inc.1990-02-08
THORA-KLEX CHEST DRAINAGE UNIT (K896127)Davol, Inc.1990-01-24
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION (K892915)Deknatel, Inc.1989-06-21
ELIMINATOR AIR FILTER (K882468)Apex Medical, Inc.1988-08-29
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST (K882223)Deknatel, Inc.1988-08-16
MUCUS TRAP OR SUCTION TRAP (K881149)Ferguson Medical1988-06-14
URESIL THORACIC VENT (K863561)Uresil Corp.1986-09-23
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES (K861025)Boehringer Laboratories1986-04-28
FILTERED VACUUM SAFETY TRAP BOTTLE (K855074)Boehringer Laboratories1986-03-13
LM2000A SURGICAL SUCTION MONITOR (K854359)Engineering, Inc.1986-03-03
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT (K860023)Atrium Medical Corp.1986-01-10
BARD PARKER THORACIC VENT (K854634)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-12-27
NIFA NON INVASIVE FLUTTER ASSEMBLY (K844853)Emergency Management Products, Inc.1985-12-12
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO (K851244)Cook, Inc.1985-11-19
COMPACT 2000 (K851892)Atrium Medical Corp.1985-06-14
ABCO SUCTION CANISTER (K851316)Abco Dealers, Inc.1985-05-08
PLURA-GARD CHEST DRAINAGE SYSTEM (K844942)Consolidated Medical Equipment, Inc.1985-03-12
THORAX-KLEX CHEST DRAINAGE UNIT (K830671)C.R. Bard, Inc.1983-03-29
THORACIC DRAINAGE SET #55-DB2-G (K812746)J. H. Emerson Co.1981-10-26
PLEURAL DRAINAGE SYSTEM #PDS-4300 (K812224)Bentley Laboratories, Inc.1981-09-09
VACUUM SUCTION FILTER (K812139)K & G Healthcare Ind., Inc.1981-08-20
MODIFIED THORACENTESIS CATHETER (K811437)Blair Medical Products1981-08-13
CALIBRATED BREATHING SYSTEM COLLECTION (K811955)Anchor Brush Co., Inc.1981-08-04
VAC-RITE SUNCTION COLLECTION (K811192)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-06-02
SUCTION COLLECTION BOTTLE, DISPOSABLE (K810574)Harvard Laboratories1981-04-21
ELECTRO-SUCTION UNIT (K810892)Jedmed Instrument Co.1981-04-17
ARGYLE SUCTION CANISTER W/DISP. LINER (K802174)Sherwood Medical Co.1980-09-26
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM (K801221)Chesebrough-Pond'S U.S.A. Co.1980-06-09
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION (K800861)Snyder Laboratories, Inc.1980-05-02
CONPHAR SILICONE DRAINS-STERILE (K791254)Conphar, Inc.1979-08-03
SEP-T-VAC SUCTION CANNISTER W/ TUBING (K790379)Sherwood Medical Co.1979-04-10
TUBES, LUKENS, TOMAS (K781234)Ludwig Medical, Inc.1978-08-10
SUCTION CANISTER (K781279)Abco Dealers, Inc.1978-08-10
VAC-RITE (K770649)Medical Development Co.1977-06-02
AQUA-SEAL (K761202)Respiratory Care, Inc.1976-12-09

Track KDQ automatically

Every clearance here is in the API, with alerts when new ones post.