FDA product code DTR: Heat-Exchanger, Cardiopulmonary Bypass
DTR is the FDA product code for heat-exchanger, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4240 and reviewed by the Cardiovascular panel. FDA has cleared 91 510(k) submissions under DTR, 7 in the last five years, from 41 different applicants. The average 510(k) review took 112 days (median 85); 179 days on average over the last three years. FDA has posted 33 recalls for DTR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Heat-Exchanger, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4240 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DTR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 115 |
| 2018 | 1 | 300 |
| 2020 | 2 | 121 |
| 2022 | 2 | 126 |
| 2023 | 1 | 107 |
| 2024 | 1 | 30 |
| 2025 | 2 | 296 |
| 2026 | 1 | 212 |
Compare with all 510(k) review times · Search every DTR clearance
Top DTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shiley, Inc. | 11 | 1991-04-09 |
| Gish Biomedical, Inc. | 10 | 2009-01-26 |
| 3M Health Care, Sarns | 6 | 1992-09-18 |
| Quest Medical, Inc. | 5 | 2020-11-20 |
| Medtronic Vascular | 4 | 2000-12-21 |
36 more applicants have DTR clearances. See the full list in Caduvo.
Most recent DTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252541 | Spectrum Medical S.R.L. | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | 2026-03-12 | 212 |
| K240908 | Spectrum Medical , Ltd. | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | 2025-07-08 | 462 |
| K250150 | Sorin Group Italia S.R.L. | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | 2025-05-30 | 129 |
| K240190 | Medtronic | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | 2024-02-23 | 30 |
| K223879 | Quara S.R.L. | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | 2023-04-13 | 107 |
Recalls for DTR devices
33 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code DTR?
DTR is the FDA product code for heat-exchanger, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4240 and reviewed by the Cardiovascular panel.
What device class is DTR?
Class II, regulation 21 CFR 870.4240. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTR?
Across 91 cleared submissions the average was 112 days from receipt to decision (median 85).
Which companies have the most DTR clearances?
Shiley, Inc. (11); Gish Biomedical, Inc. (10); 3M Health Care, Sarns (6); Quest Medical, Inc. (5); Medtronic Vascular (4).
Have DTR devices been recalled?
Yes: 33 product recalls across 10 recall events; the most recent began 2023-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code DTR
- Run a recall and safety report across every DTR manufacturer
- Watch product code DTR 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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