JOJ — Indicator, Physical/Chemical Sterilization Process Class II
FDA Device Classification
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 |