FDA product code DWA: Control, Pump Speed, Cardiopulmonary Bypass
DWA is the FDA product code for control, pump speed, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4380 and reviewed by the Cardiovascular panel. FDA has cleared 37 510(k) submissions under DWA, 3 in the last five years, from 19 different applicants. The average 510(k) review took 115 days (median 83); 256 days on average over the last three years. FDA has posted 12 recalls for DWA devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Control, Pump Speed, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DWA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 28 |
| 2020 | 2 | 111 |
| 2023 | 2 | 146 |
| 2024 | 1 | 256 |
Compare with all 510(k) review times · Search every DWA clearance
Top DWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Levitronix, LLC | 6 | 2010-08-27 |
| Medtronic Bio-Medicus, Inc. | 6 | 1994-12-23 |
| Sorin Group Deutschland GmbH | 3 | 2011-09-20 |
| Stockert Instrumente GmbH | 3 | 2004-09-23 |
| Bio Medicus, Inc. | 3 | 1990-06-28 |
14 more applicants have DWA clearances. See the full list in Caduvo.
Most recent DWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232788 | Inspira Technologies Oxy B.H.N. , Ltd. | INSPIRA ART100 | 2024-05-24 | 256 |
| K230698 | Apmtd, Inc. | Anivia SG1000 Pump Console | 2023-04-18 | 36 |
| K221491 | Apmtd, Inc. | Anivia SG1000 Pump Console | 2023-02-03 | 256 |
| K192838 | Spectrum Medical , Ltd. | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | 2020-04-13 | 193 |
| K200306 | Abbott (Formerly Thoratec Corporation) | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | 2020-03-06 | 29 |
Recalls for DWA devices
12 product recalls in 10 recall events; 3 initiated in the last five years and 1 still open. Most recent: 2022-12-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code DWA?
DWA is the FDA product code for control, pump speed, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4380 and reviewed by the Cardiovascular panel.
What device class is DWA?
Class II, regulation 21 CFR 870.4380. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWA?
Across 37 cleared submissions the average was 115 days from receipt to decision (median 83).
Which companies have the most DWA clearances?
Levitronix, LLC (6); Medtronic Bio-Medicus, Inc. (6); Sorin Group Deutschland GmbH (3); Stockert Instrumente GmbH (3); Bio Medicus, Inc. (3).
Have DWA devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2022-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DWA
- Run a recall and safety report across every DWA manufacturer
- Watch product code DWA 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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