FDA product code DWC: Controller, Temperature, Cardiopulmonary Bypass
DWC is the FDA product code for controller, temperature, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4250 and reviewed by the Cardiovascular panel. FDA has cleared 30 510(k) submissions under DWC, 2 in the last five years, from 22 different applicants. The average 510(k) review took 114 days (median 86). FDA has posted 52 recalls for DWC devices, 5 initiated in the last five years.
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Controller, Temperature, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DWC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 277 |
| 2022 | 2 | 256 |
Compare with all 510(k) review times · Search every DWC clearance
Top DWC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Daily Medical Products, Inc. | 5 | 1990-02-05 |
| Livanova Deutschland, GmbH | 2 | 2022-11-16 |
| Sorin Group Deutschland GmbH | 2 | 2014-01-31 |
| 3M Health Care, Sarns | 2 | 1988-11-03 |
| Gambro, Inc. | 2 | 1983-07-18 |
17 more applicants have DWC clearances. See the full list in Caduvo.
Most recent DWC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220635 | Livanova Deutschland, GmbH | Heater-Cooler System 3T | 2022-11-16 | 257 |
| K212657 | Spectrum Medical , Ltd. | Quantum Heater-Cooler | 2022-05-06 | 256 |
| K191402 | Livanova Deutschland, GmbH | Heater-Cooler System 3T | 2020-02-25 | 277 |
| K140012 | Sorin Group Deutschland GmbH | SORIN FLEXTHERM | 2014-01-31 | 29 |
| K130300 | Maquet Cardiopulmonary, AG | HEATER-COOLER UNIT HCU 40 | 2013-07-01 | 144 |
Recalls for DWC devices
52 product recalls in 29 recall events; 5 initiated in the last five years and 10 still open. Most recent: 2023-10-24.
| Year | Recalls |
|---|---|
| 2017 | 8 |
| 2018 | 8 |
| 2020 | 1 |
| 2021 | 10 |
| 2023 | 5 |
Frequently asked questions
What is FDA product code DWC?
DWC is the FDA product code for controller, temperature, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4250 and reviewed by the Cardiovascular panel.
What device class is DWC?
Class II, regulation 21 CFR 870.4250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWC?
Across 30 cleared submissions the average was 114 days from receipt to decision (median 86).
Which companies have the most DWC clearances?
Daily Medical Products, Inc. (5); Livanova Deutschland, GmbH (2); Sorin Group Deutschland GmbH (2); 3M Health Care, Sarns (2); Gambro, Inc. (2).
Have DWC devices been recalled?
Yes: 52 product recalls across 29 recall events; the most recent began 2023-10-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DWC
- Run a recall and safety report across every DWC manufacturer
- Watch product code DWC 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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