FDA product code DWM: Apparatus, Suction, Patient Care
DWM is the FDA product code for apparatus, suction, patient care. It is a Class II device, regulated under 21 CFR 870.5050 and reviewed by the Anesthesiology panel. FDA has cleared 19 510(k) submissions under DWM, 1 in the last five years, from 10 different applicants. The average 510(k) review took 142 days (median 115). FDA has posted 3 recalls for DWM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Suction, Patient Care |
| Device class | Class II |
| Regulation | 21 CFR 870.5050 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2019 | 1 | 164 |
| 2020 | 1 | 176 |
| 2021 | 1 | 199 |
| 2023 | 1 | 555 |
Compare with all 510(k) review times · Search every DWM clearance
Top DWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Care Fusion | 4 | 2016-10-31 |
| Rocket Medical Plc | 3 | 2021-09-09 |
| Bearpac Medical | 2 | 2020-11-20 |
| C.R. Bard, Inc. | 2 | 2011-05-11 |
| Denver Biomedical, Inc. | 2 | 2005-10-06 |
5 more applicants have DWM clearances. See the full list in Caduvo.
Most recent DWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212696 | Merit Medical Systems, Inc. | Aspira Pleural Drainage System | 2023-03-03 | 555 |
| K210509 | Rocket Medical Plc | Rocket Platinum Cured Cathter | 2021-09-09 | 199 |
| K201404 | Bearpac Medical | Passio Pump Drainage System | 2020-11-20 | 176 |
| K190292 | Bearpac Medical | Passio Pump Drainage System | 2019-07-25 | 164 |
| K163321 | Rocket Medical Plc | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | 2017-08-17 | 265 |
Recalls for DWM devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0379 — Direct admission of patient for hospital observation care
Frequently asked questions
What is FDA product code DWM?
DWM is the FDA product code for apparatus, suction, patient care. It is a Class II device, regulated under 21 CFR 870.5050 and reviewed by the Anesthesiology panel.
What device class is DWM?
Class II, regulation 21 CFR 870.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWM?
Across 19 cleared submissions the average was 142 days from receipt to decision (median 115).
Which companies have the most DWM clearances?
Care Fusion (4); Rocket Medical Plc (3); Bearpac Medical (2); C.R. Bard, Inc. (2); Denver Biomedical, Inc. (2).
Have DWM devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code DWM
- Run a recall and safety report across every DWM manufacturer
- Watch product code DWM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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