FDA product code DWE: Tubing, Pump, Cardiopulmonary Bypass
DWE is the FDA product code for tubing, pump, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4390 and reviewed by the Cardiovascular panel. FDA has cleared 21 510(k) submissions under DWE, 1 in the last five years, from 18 different applicants. The average 510(k) review took 102 days (median 85); 265 days on average over the last three years. FDA has posted 48 recalls for DWE devices.
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Pump, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4390 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 265 |
Compare with all 510(k) review times · Search every DWE clearance
Top DWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Terumo Cardiovascular Systems Corporation | 2 | 2015-05-01 |
| Maquet Cardiopulmonary, AG | 2 | 2008-09-11 |
| 3M Health Care, Sarns | 2 | 1991-02-25 |
| LivaNova USA, Inc. | 1 | 2024-08-08 |
| Angiodynamics | 1 | 2014-12-11 |
13 more applicants have DWE clearances. See the full list in Caduvo.
Most recent DWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233702 | LivaNova USA, Inc. | SMARxT Tubing and Connectors | 2024-08-08 | 265 |
| K150542 | Terumo Cardiovascular Systems Corporation | Terumo Pump Tubing | 2015-05-01 | 59 |
| K142607 | Angiodynamics | AngioVac Circuit | 2014-12-11 | 87 |
| K092486 | Vortex Medical, Inc. | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | 2009-08-28 | 15 |
| K080592 | Maquet Cardiopulmonary, AG | HLM TUBING SET WITH BIOLINE COATING | 2008-09-11 | 192 |
Recalls for DWE devices
48 product recalls in 23 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-07-03.
| Year | Recalls |
|---|---|
| 2017 | 28 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code DWE?
DWE is the FDA product code for tubing, pump, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4390 and reviewed by the Cardiovascular panel.
What device class is DWE?
Class II, regulation 21 CFR 870.4390. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWE?
Across 21 cleared submissions the average was 102 days from receipt to decision (median 85).
Which companies have the most DWE clearances?
Terumo Cardiovascular Systems Corporation (2); Maquet Cardiopulmonary, AG (2); 3M Health Care, Sarns (2); LivaNova USA, Inc. (1); Angiodynamics (1).
Have DWE devices been recalled?
Yes: 48 product recalls across 23 recall events; the most recent began 2019-07-03.
Next steps
- Run an FDA pathway report with predicate devices for product code DWE
- Run a recall and safety report across every DWE manufacturer
- Watch product code DWE 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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