FDA product code DTZ: Oxygenator, Cardiopulmonary Bypass
DTZ is the FDA product code for oxygenator, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4350 and reviewed by the Cardiovascular panel. FDA has cleared 255 510(k) submissions under DTZ, 15 in the last five years, from 62 different applicants. The average 510(k) review took 134 days (median 88); 292 days on average over the last three years. FDA has posted 107 recalls for DTZ devices, 33 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4350 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DTZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 54 |
| 2018 | 3 | 121 |
| 2019 | 5 | 76 |
| 2020 | 5 | 158 |
| 2021 | 5 | 299 |
| 2022 | 2 | 153 |
| 2023 | 5 | 129 |
| 2024 | 3 | 196 |
| 2025 | 2 | 364 |
| 2026 | 3 | 316 |
Compare with all 510(k) review times · Search every DTZ clearance
Top DTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sorin Group Italia S.R.L. | 22 | 2023-11-16 |
| Medtronic, Inc. | 15 | 2024-06-12 |
| Maquet Cardiopulmonary, AG | 13 | 2015-05-07 |
| American Bentley | 13 | 1987-11-06 |
| Medtronic Vascular | 12 | 2000-02-25 |
57 more applicants have DTZ clearances. See the full list in Caduvo.
Most recent DTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261438 | Eurosets S.R.L | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | 2026-09-14 | 137 |
| K253838 | Lifemotion Medical Technology Co., Ltd. | Lifemotion Disposable Membrane Oxygenator | 2026-03-16 | 105 |
| K240934 | Spectrum Medical S.R.L. | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | 2026-03-12 | 706 |
| K250821 | Eurosets S.R.L | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | 2025-12-12 | 269 |
| K242503 | Eurosets S.R.L | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | 2025-11-24 | 459 |
Recalls for DTZ devices
107 product recalls in 43 recall events; 33 initiated in the last five years and 33 still open. Most recent: 2025-09-12.
| Year | Recalls |
|---|---|
| 2018 | 5 |
| 2019 | 6 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 10 |
| 2023 | 19 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DTZ?
DTZ is the FDA product code for oxygenator, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4350 and reviewed by the Cardiovascular panel.
What device class is DTZ?
Class II, regulation 21 CFR 870.4350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTZ?
Across 255 cleared submissions the average was 134 days from receipt to decision (median 88).
Which companies have the most DTZ clearances?
Sorin Group Italia S.R.L. (22); Medtronic, Inc. (15); Maquet Cardiopulmonary, AG (13); American Bentley (13); Medtronic Vascular (12).
Have DTZ devices been recalled?
Yes: 107 product recalls across 43 recall events; the most recent began 2025-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DTZ
- Run a recall and safety report across every DTZ manufacturer
- Watch product code DTZ 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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