Atlas FDA

DWM

19 FDA 510(k) clearances · Product code

115 daysmedian time to decision
346 days90th percentile
19clearances measured

FDA profile

Official device name
Apparatus, Suction, Patient Care
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5050
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 143 · 2022: 62 · 2023: 108 · 2024: 70 · 2025: 74 · 2026: 57
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Aspira Pleural Drainage System (K212696)Merit Medical Systems, Inc.2023-03-03
Rocket Platinum Cured Cathter (K210509)Rocket Medical Plc2021-09-09
Passio Pump Drainage System (K201404)Bearpac Medical2020-11-20
Passio Pump Drainage System (K190292)Bearpac Medical2019-07-25
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (K163321)Rocket Medical Plc2017-08-17
Pleurx Pleural Catheter System (K160450)Care Fusion2016-10-31
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (K141965)Care Fusion2015-07-02
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B (K123033)Rocket Medical Plc2013-02-01
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (K121849)Care Fusion2012-10-18
PLEURX PLEURAL CATHETER SYSTEMS (K112831)Care Fusion2012-02-16
ASPIRA PLEURAL DRAINAGE SYSTEM (K110409)C.R. Bard, Inc.2011-05-11
ASEPT PLEURAL DRAINAGE SYSTEM (K093307)Pfm Medical, Inc.2009-11-06
ASPIRA PLEURAL DRAINAGE SYSTEM (K071095)Bard Access Systems, Inc.2007-05-18
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 (K052436)Denver Biomedical, Inc.2005-10-06
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (K051084)Denver Biomedicals, Inc.2005-06-13
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS (K011831)Denver Biomedical, Inc.2001-06-28
PLEURX PLEURAL CATHETER AND DRAINAGE KITS (K010642)Denver Biomedicals, Inc.2001-03-20
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 (K971753)Denver Biomaterials, Inc.1997-06-27
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN (K803037)C.R. Bard, Inc.1981-02-04

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