FDA product code DTW: Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
DTW is the FDA product code for monitor and/or control, level sensing, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4340 and reviewed by the Cardiovascular panel. FDA has cleared 17 510(k) submissions under DTW, from 15 different applicants. The average 510(k) review took 123 days (median 77). FDA has posted 15 recalls for DTW devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4340 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTW clearance
Top DTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gambro, Inc. | 2 | 1986-05-30 |
| 3M Health Care, Sarns | 2 | 1983-07-26 |
| Medtronic, Inc. | 1 | 2015-05-08 |
| Stockert Instrumente GmbH | 1 | 2004-07-02 |
| Rocky Mountain Research, Inc. | 1 | 1999-11-10 |
10 more applicants have DTW clearances. See the full list in Caduvo.
Most recent DTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150530 | Medtronic, Inc. | Level Sensor, Level Sensor Tape | 2015-05-08 | 67 |
| K041558 | Stockert Instrumente GmbH | STOCKERTIR PURGE CONTROL (APC) SYSTEM | 2004-07-02 | 22 |
| K992857 | Rocky Mountain Research, Inc. | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | 1999-11-10 | 77 |
| K955152 | Stoeckert Instrumente | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | 1996-02-22 | 101 |
| K910599 | Jtl Medical Corp. | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | 1993-05-20 | 827 |
Recalls for DTW devices
15 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-01-12.
Frequently asked questions
What is FDA product code DTW?
DTW is the FDA product code for monitor and/or control, level sensing, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4340 and reviewed by the Cardiovascular panel.
What device class is DTW?
Class II, regulation 21 CFR 870.4340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTW?
Across 17 cleared submissions the average was 123 days from receipt to decision (median 77).
Which companies have the most DTW clearances?
Gambro, Inc. (2); 3M Health Care, Sarns (2); Medtronic, Inc. (1); Stockert Instrumente GmbH (1); Rocky Mountain Research, Inc. (1).
Have DTW devices been recalled?
Yes: 15 product recalls across 2 recall events; the most recent began 2007-01-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DTW
- Run a recall and safety report across every DTW manufacturer
- Watch product code DTW 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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