DWM · Class II · 21 CFR 870.5050

FDA Product Code DWM: Apparatus, Suction, Patient Care

Leading manufacturers include Care Fusion, Rocket Medical Plc and Bearpac Medical.

19
Total
19
Cleared
142d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Apparatus, Suction, Patient Care Devices (Product Code DWM)

19 devices
1–19 of 19
Cleared Mar 03, 2023
Aspira Pleural Drainage System
K212696
Merit Medical Systems, Inc.
Anesthesiology · 555d
Cleared Sep 09, 2021
Rocket Platinum Cured Cathter
K210509
Rocket Medical Plc
Gastroenterology & Urology · 199d
Cleared Nov 20, 2020
Passio Pump Drainage System
K201404
Bearpac Medical
Anesthesiology · 176d
Cleared Jul 25, 2019
Passio Pump Drainage System
K190292
Bearpac Medical
Anesthesiology · 164d
Cleared Aug 17, 2017
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
K163321
Rocket Medical Plc
Anesthesiology · 265d
Cleared Oct 31, 2016
Pleurx Pleural Catheter System
K160450
Care Fusion
Anesthesiology · 256d
Cleared Jul 02, 2015
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K141965
Care Fusion
Anesthesiology · 346d
Cleared Feb 01, 2013
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
K123033
Rocket Medical Plc
Anesthesiology · 126d
Cleared Oct 18, 2012
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
K121849
Care Fusion
Anesthesiology · 115d
Cleared Feb 16, 2012
PLEURX PLEURAL CATHETER SYSTEMS
K112831
Care Fusion
Anesthesiology · 141d
Cleared May 11, 2011
ASPIRA PLEURAL DRAINAGE SYSTEM
K110409
C.R. Bard, Inc.
Anesthesiology · 86d
Cleared Nov 06, 2009
ASEPT PLEURAL DRAINAGE SYSTEM
K093307
Pfm Medical, Inc.
Anesthesiology · 15d
Cleared May 18, 2007
ASPIRA PLEURAL DRAINAGE SYSTEM
K071095
Bard Access Systems, Inc.
Anesthesiology · 30d
Cleared Jun 13, 2005
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
K051084
Denver Biomedicals, Inc.
Anesthesiology · 46d
Cleared Jun 27, 1997
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
K971753
Denver Biomaterials, Inc.
Anesthesiology · 46d
Cleared Feb 04, 1981
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN
K803037
C.R. Bard, Inc.
Anesthesiology · 65d

About Product Code DWM - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code DWM since 1981, with 19 receiving FDA clearance (average review time: 142 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.