DWM · Class II · 21 CFR 870.5050

FDA Product Code DWM: Apparatus, Suction, Patient Care

Leading manufacturers include C.R. Bard, Inc., Bearpac Medical and Rocket Medical Plc.

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 May 11, 2011
ASPIRA PLEURAL DRAINAGE SYSTEM
K110409
C.R. Bard, Inc.
Anesthesiology · 86d
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.