FDA product code DTN: Reservoir, Blood, Cardiopulmonary Bypass
DTN is the FDA product code for reservoir, blood, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel. FDA has cleared 169 510(k) submissions under DTN, 4 in the last five years, from 48 different applicants. The average 510(k) review took 109 days (median 79); 124 days on average over the last three years. FDA has posted 47 recalls for DTN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Reservoir, Blood, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DTN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 138 |
| 2023 | 1 | 219 |
| 2024 | 2 | 54 |
| 2025 | 1 | 194 |
Compare with all 510(k) review times · Search every DTN clearance
Top DTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gish Biomedical, Inc. | 16 | 2009-08-04 |
| Shiley, Inc. | 14 | 1991-08-09 |
| American Bentley | 11 | 1985-09-25 |
| C.R. Bard, Inc. | 10 | 1998-08-05 |
| Cobe Cardiovascular, Inc. | 9 | 2005-03-08 |
43 more applicants have DTN clearances. See the full list in Caduvo.
Most recent DTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251783 | Sorin Group Italia S.R.L. | Inspire HCR and HCR DUAL cardiotomy reservoirs | 2025-12-22 | 194 |
| K241206 | Spectrum Medical S.R.L. | Quantum Perfusion Hybrid System | 2024-07-18 | 79 |
| K241053 | Medtronic Cardiac Surgery | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL | 2024-05-15 | 28 |
| K223361 | Sorin Group Italia S.R.L. | BMR 1900 PHISIO | 2023-06-10 | 219 |
| K170583 | Medtronic, Inc. | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | 2017-03-17 | 17 |
Recalls for DTN devices
47 product recalls in 15 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2023-05-18.
| Year | Recalls |
|---|---|
| 2017 | 24 |
| 2018 | 2 |
| 2021 | 11 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code DTN?
DTN is the FDA product code for reservoir, blood, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel.
What device class is DTN?
Class II, regulation 21 CFR 870.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTN?
Across 169 cleared submissions the average was 109 days from receipt to decision (median 79).
Which companies have the most DTN clearances?
Gish Biomedical, Inc. (16); Shiley, Inc. (14); American Bentley (11); C.R. Bard, Inc. (10); Cobe Cardiovascular, Inc. (9).
Have DTN devices been recalled?
Yes: 47 product recalls across 15 recall events; the most recent began 2023-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code DTN
- Run a recall and safety report across every DTN manufacturer
- Watch product code DTN 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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