JOJ — Indicator, Physical/Chemical Sterilization Process Class II
FDA product code JOJ covers "Indicator, Physical/Chemical Sterilization Process", a Class II medical device regulated under 21 CFR 880.2800. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOJ
- Device Class
- Class II
- Regulation Number
- 880.2800
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260181 | intertape polymer group | LF Process Indicator Tape for Steam Sterilization | February 20, 2026 |
| K251991 | shenzhen safesecure medical infection control tech co. | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeS | December 23, 2025 |
| K251035 | serim research | DISINTEK PA Test Strips | June 3, 2025 |
| K251048 | steris corporation | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | May 2, 2025 |
| K243876 | steris corporation | VERIFY STEAM Integrating Indicator | April 25, 2025 |
| K250172 | steritec products, inc. (a getinge company) | Green Card Bowie-Dick Test (BD115) | February 20, 2025 |
| K242860 | true indicating | Type 5 Integrating Indicator for Steam (CSPN-15) | January 17, 2025 |
| K241036 | jiangmen new era external use drug co | Autoclave Indicator Tape; EO Indicator Tape | December 17, 2024 |
| K243475 | steris corporation | Chemical Indicator for enspire CLCSPS (LCC015) | December 4, 2024 |
| K242795 | steritec products mfg. (a getinge group company) | Getinge Assured MI Steam Migrating Integrator | October 15, 2024 |
| K241836 | kem medical products corporation | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | September 30, 2024 |
| K242189 | steris | CELERITY HP Indicator Tape (PCC077) | August 20, 2024 |
| K234084 | advanced sterilization products | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indi | July 5, 2024 |
| K233413 | true indicating | Ultraphon Chemical Indicator (TRO-T and TRO-B) | June 26, 2024 |
| K240910 | propper manufacturing co | EO Chex Indicator Tape | June 12, 2024 |
| K241344 | steris | MetriCide OPA Plus Solution Test Strip | June 11, 2024 |
| DEN230068 | 3m | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 1013 | May 21, 2024 |
| K240032 | steris corporation | Celerity Chemical Indicator for enspire 3000 CLCSPS | April 17, 2024 |
| K240760 | steris | CELERITY HP Indicator Tape | April 10, 2024 |
| K233654 | steris | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Ste | December 8, 2023 |