← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
JOJ — Indicator, Physical/Chemical 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
K260181Intertape Polymer Group · 510k2026-02-20
K251991Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · 510k2025-12-23
K251035Serim Research · 510k2025-06-03
K251048STERIS Corporation · 510k2025-05-02
K243876STERIS Corporation · 510k2025-04-25
K250172Steritec Products, Inc. (A Getinge Company) · 510k2025-02-20
K242860True Indicating, LLC · 510k2025-01-17
K241036Jiangmen New Era External Use Drug Co., Ltd. · 510k2024-12-17
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.
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