Product code DTZ: 510(k) clearances and predicates
Product code DTZ covers HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305). FDA lists 255 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
255 clearances on file under product code DTZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 so far | 3 |
Recent clearances
Newest DTZ clearances in the FDA index, with applicant and decision date:
- K261438, HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305), applicant Eurosets S.R.L, decided 2026-09-14. FDA record
- K253838, Lifemotion Disposable Membrane Oxygenator, applicant Lifemotion Medical Technology Co., Ltd., decided 2026-03-16. FDA record
- K240934, 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);, applicant Spectrum Medical S.R.L., decided 2026-03-12. FDA record
- K250821, 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), applicant Eurosets S.R.L, decided 2025-12-12. FDA record
- K242503, Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232), applicant Eurosets S.R.L, decided 2025-11-24. FDA record
- K231982, Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2, applicant Qura S.R.L, decided 2024-09-12. FDA record
- K240666, Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS), applicant Medtronic Perfusion Systems, decided 2024-07-10. FDA record
- K241352, Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B), applicant Medtronic, Inc., decided 2024-06-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Lifemotion Disposable Membrane Oxygenator, 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);. Watch new DTZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DTZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DTZ clearances include HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305).
How many 510(k) clearances use product code DTZ?
255 at the time this page was generated, from openFDA records.
How do I find a predicate device under DTZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DTZ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.