FDA product code DTM: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
DTM is the FDA product code for filter, blood, cardiopulmonary bypass, arterial line. It is a Class II device, regulated under 21 CFR 870.4260 and reviewed by the Cardiovascular panel. FDA has cleared 96 510(k) submissions under DTM, 4 in the last five years, from 38 different applicants. The average 510(k) review took 99 days (median 70); 164 days on average over the last three years. FDA has posted 5 recalls for DTM devices.
Classification
| Field | Value |
|---|---|
| Device name | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device class | Class II |
| Regulation | 21 CFR 870.4260 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DTM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 173 |
| 2024 | 2 | 105 |
| 2026 | 1 | 224 |
Compare with all 510(k) review times · Search every DTM clearance
Top DTM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sorin Group Italia S.R.L. | 6 | 2024-12-20 |
| Bentley Laboratories, Inc. | 6 | 1982-06-29 |
| Terumo Cardiovascular Systems Corp. | 5 | 2009-08-20 |
| Pall Biomedical Products Co. | 5 | 1990-10-16 |
| American Bentley | 5 | 1985-01-08 |
33 more applicants have DTM clearances. See the full list in Caduvo.
Most recent DTM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251744 | Medtronic | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | 2026-01-16 | 224 |
| K242953 | Sorin Group Italia S.R.L. | KIDS Arterial Filters | 2024-12-20 | 86 |
| K242092 | Sorin Group Italia S.R.L. | MICRO Arterial Filters | 2024-11-18 | 124 |
| K231362 | TransMedics, Inc. | OCS Heart Leukocyte Depleting Filter | 2023-10-31 | 173 |
| K123351 | Medtronic Perfusion Systems | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | 2013-03-19 | 139 |
Recalls for DTM devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-14.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code DTM?
DTM is the FDA product code for filter, blood, cardiopulmonary bypass, arterial line. It is a Class II device, regulated under 21 CFR 870.4260 and reviewed by the Cardiovascular panel.
What device class is DTM?
Class II, regulation 21 CFR 870.4260. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTM?
Across 96 cleared submissions the average was 99 days from receipt to decision (median 70).
Which companies have the most DTM clearances?
Sorin Group Italia S.R.L. (6); Bentley Laboratories, Inc. (6); Terumo Cardiovascular Systems Corp. (5); Pall Biomedical Products Co. (5); American Bentley (5).
Have DTM devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2019-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DTM
- Run a recall and safety report across every DTM manufacturer
- Watch product code DTM 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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