510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DWMClass II

Apparatus, Suction, Patient Care

21 CFR 870.5050 / Cardiovascular
FDA source (opens on fda.gov)

DWM is the FDA product code for Apparatus, Suction, Patient Care, a class II device type, regulated under 21 CFR 870.5050. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
DWM
Device name
Apparatus, Suction, Patient Care
Regulation
21 CFR 870.5050
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
3

Clearances, product code DWM

By decision year
19 clearances under product code DWM with a decision year between 1981 and 2023, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DWM by decision year
YearClearances
19811
19971
20012
20052
20071
20091
20111
20122
20131
20151
20161
20171
20191
20201
20211
20231

Applicants with the most clearances

Product code DWM
Applicants holding the most 510(k) clearances under product code DWM
ApplicantClearances
Care Fusion4
Rocket Medical3
Bearpac Medical, LLC2
C.R. Bard Inc2
Denver Biomedical, Inc.2
Denver Biomedicals, Inc.2
Bard Access Systems, Inc.1
Denver Biomaterials, Inc.1
Merit Medical Systems, Inc.1
PFM Medical GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order