← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
FRC — Indicator, Biological Sterilization Process
DEVICE CLASS
Class II
REGULATION
21 CFR 880.2800
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES
Recent clearances
K260766STERIS Corporation · 510k2026-04-08
K252680STERIS Corporation · 510k2025-09-24
K251122Terragene · 510k2025-08-04
K251452Steris · 510k2025-06-06
K250044STERIS Corporation · 510k2025-02-06
K250061STERIS Corporation · 510k2025-02-06
K2435013M Company · 510k2025-01-28
K242453Terragene S.A. · 510k2024-12-12
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.