Product code FRC: 510(k) clearances and predicates
Product code FRC covers Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045). FDA lists 206 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
206 clearances on file under product code FRC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 6 |
| 2024 | 8 |
| 2025 | 6 |
| 2026 so far | 1 |
Recent clearances
Newest FRC clearances in the FDA index, with applicant and decision date:
- K260766, Celerity 5 HP Biological Indicator (LCB052), applicant STERIS Corporation, decided 2026-04-08. FDA record
- K252680, Celerity 20 HP Biological Indicator, applicant STERIS Corporation, decided 2025-09-24. FDA record
- K251122, Terragene® Bionova® BT20 Biological Indicator, applicant Terragene, decided 2025-08-04. FDA record
- K251452, Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045), applicant Steris, decided 2025-06-06. FDA record
- K250044, Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045), applicant STERIS Corporation, decided 2025-02-06. FDA record
- K250061, Celerity Incubator, applicant STERIS Corporation, decided 2025-02-06. FDA record
- K243501, 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M, applicant 3M Company, decided 2025-01-28. FDA record
- K242453, Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C), applicant Terragene S.A., decided 2024-12-12. 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 Celerity 5 HP Biological Indicator (LCB052), Celerity 20 HP Biological Indicator. Watch new FRC 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 FRC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FRC clearances include Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045).
How many 510(k) clearances use product code FRC?
206 at the time this page was generated, from openFDA records.
How do I find a predicate device under FRC?
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 FRC 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.