Product code CBK: 510(k) clearances and predicates
Product code CBK covers Evita (V800); Evita (V600). FDA lists 505 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
505 clearances on file under product code CBK. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 5 |
| 2024 | 9 |
| 2025 | 4 |
| 2026 so far | 3 |
Recent clearances
Newest CBK clearances in the FDA index, with applicant and decision date:
- K253647, Evita (V800); Evita (V600), applicant Draegerwerk AG & CO Kgaa, decided 2026-05-07. FDA record
- K252663, Inbentus Versatile, applicant Iconic Solutions by Murcia, SL, decided 2026-04-14. FDA record
- K251888, VPAP Pediatric Face Mask, applicant Hsiner Co., Ltd., decided 2026-03-12. FDA record
- K232365, Vivo 45 LS, applicant Oconnell Regulatory Consultants, Inc., decided 2025-12-19. FDA record
- K252173, F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full, applicant Fisher & Paykel Healthcare, Ltd., decided 2025-09-10. FDA record
- K243767, SV600, SV800 Ventilator, applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd., decided 2025-08-28. FDA record
- K251133, AVEA disposable expiratory filter/water trap (11790), applicant Telesair, Inc., decided 2025-05-08. FDA record
- K243394, AF531 Oro-Nasal SE Face Mask, applicant Respironics, Inc., decided 2024-12-30. 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 Inbentus Versatile, VPAP Pediatric Face Mask. Watch new CBK 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 CBK?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CBK clearances include Evita (V800); Evita (V600).
How many 510(k) clearances use product code CBK?
505 at the time this page was generated, from openFDA records.
How do I find a predicate device under CBK?
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 CBK clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.