Product code OWB: 510(k) clearances and predicates
Product code OWB covers uAngio AVIVA CX. FDA lists 325 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
325 clearances on file under product code OWB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 21 |
| 2023 | 12 |
| 2024 | 13 |
| 2025 | 22 |
| 2026 so far | 15 |
Recent clearances
Newest OWB clearances in the FDA index, with applicant and decision date:
- K253726, uAngio AVIVA CX, applicant Shanghai United Imaging Healthcare Co., Ltd., decided 2026-08-21. FDA record
- K261413, EXTRON 3;EXTRON 6, applicant DRTECH Corporation, decided 2026-08-19. FDA record
- K254205, Zenition 30, applicant Philips Medical Systems Nederland B.V., decided 2026-08-07. FDA record
- K260607, Shield System (Siemens 30x40), applicant Radiaction , Ltd., decided 2026-07-31. FDA record
- K253670, SmartCT (R3.0 (L10)), applicant Philips Medical Systems B.V., decided 2026-07-10. FDA record
- K252735, C-beam, applicant Pulmera, Inc., decided 2026-05-22. FDA record
- K252503, Intelligent NR, applicant Canon, Inc., decided 2026-04-30. FDA record
- K254173, ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno, applicant Siemens Medical Solutions USA, Inc., decided 2026-04-24. 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 EXTRON 3;EXTRON 6, Zenition 30. Watch new OWB 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 OWB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent OWB clearances include uAngio AVIVA CX.
How many 510(k) clearances use product code OWB?
325 at the time this page was generated, from openFDA records.
How do I find a predicate device under OWB?
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 OWB clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.