JOJ · Indicator, Physical/Chemical Sterilization Process
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | JOJ |
|---|---|
| Device Name | Indicator, Physical/Chemical Sterilization Process |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 265)
Showing 20 most recent of 265 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | Feb 20, 2026 | SESE |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | Dec 23, 2025 | SESE |
| K251035 | DISINTEK PA Test Strips | Serim Research | Jun 3, 2025 | SESE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | May 2, 2025 | SESE |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | Apr 25, 2025 | SESE |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | Feb 20, 2025 | SESE |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | Jan 17, 2025 | SESE |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | Dec 17, 2024 | SESE |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | Dec 4, 2024 | SESE |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | Oct 15, 2024 | SESE |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | Sep 30, 2024 | SESE |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | Aug 20, 2024 | SESE |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | Advanced Sterilization Products, Inc. | Jul 5, 2024 | SESE |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | Jun 26, 2024 | SESE |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | Jun 12, 2024 | SESE |
| K241344 | MetriCide OPA Plus Solution Test Strip | Steris | Jun 11, 2024 | SESE |
| DEN230068 | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 | 3M Company | May 21, 2024 | DENG |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | Apr 17, 2024 | SESE |
| K240760 | CELERITY HP Indicator Tape | Steris | Apr 10, 2024 | SESE |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Steris | Dec 8, 2023 | SESE |
Top Applicants
- STERIS Corporation — 36 clearances
- 3M Company — 25 clearances
- Spsmedical Supply Corp. — 17 clearances
- Albert Browne , Ltd. — 16 clearances
- Steritec Products Mfg Co, Inc. — 16 clearances
