Product code FOZ: 510(k) clearances and predicates
Product code FOZ covers Ruby Intravascular Catheter. FDA lists 508 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
508 clearances on file under product code FOZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 9 |
| 2024 | 6 |
| 2025 | 11 |
| 2026 so far | 7 |
Recent clearances
Newest FOZ clearances in the FDA index, with applicant and decision date:
- K260432, Ruby Intravascular Catheter, applicant Venocare, Inc., decided 2026-09-02. FDA record
- K260165, Unimpregnated Central Venous Catheter, applicant Spectrum Vascular, decided 2026-08-10. FDA record
- K261041, ClearSafe Closed System, applicant MedSource Labs, LLC, decided 2026-07-10. FDA record
- K260539, MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter, applicant MedSource Labs, LLC, decided 2026-07-09. FDA record
- K253235, Introcan Safety® Deep Access XL IV Catheter, applicant B.Braun Medical, Inc., decided 2026-05-15. FDA record
- K252137, BD Insyte IV Catheter, applicant Becton Dickinson Infusion Therapy Systems, Inc., decided 2026-04-02. FDA record
- K252513, Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm), applicant Poly Medicure Limited, decided 2026-04-01. FDA record
- K252398, SURFLO Hybria Closed System Safety IV Catheter, applicant Terumo Medical Products (Hangzhou) Co., Ltd., decided 2025-12-17. 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 Unimpregnated Central Venous Catheter, ClearSafe Closed System. Watch new FOZ 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 FOZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FOZ clearances include Ruby Intravascular Catheter.
How many 510(k) clearances use product code FOZ?
508 at the time this page was generated, from openFDA records.
How do I find a predicate device under FOZ?
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 FOZ 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.