Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2800](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2800) → JOJ — Indicator, Physical/Chemical Sterilization Process # JOJ · Indicator, Physical/Chemical Sterilization Process _General Hospital · 21 CFR 880.2800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ ## Overview - **Product Code:** JOJ - **Device Name:** Indicator, Physical/Chemical Sterilization Process - **Regulation:** [21 CFR 880.2800](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2800) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K260181.md) | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | Feb 20, 2026 | SESE | | [K251991](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K251991.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K251035.md) | DISINTEK™ PA Test Strips | Serim Research | Jun 3, 2025 | SESE | | [K251048](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K251048.md) | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | May 2, 2025 | SESE | | [K243876](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K243876.md) | VERIFY STEAM Integrating Indicator | STERIS Corporation | Apr 25, 2025 | SESE | | [K250172](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K250172.md) | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | Feb 20, 2025 | SESE | | [K242860](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K242860.md) | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | Jan 17, 2025 | SESE | | [K241036](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K241036.md) | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | Dec 17, 2024 | SESE | | [K243475](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K243475.md) | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | Dec 4, 2024 | SESE | | [K242795](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K242795.md) | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | Oct 15, 2024 | SESE | | [K241836](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K241836.md) | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | Sep 30, 2024 | SESE | | [K242189](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K242189.md) | CELERITY HP Indicator Tape (PCC077) | Steris | Aug 20, 2024 | SESE | | [K234084](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K234084.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K233413.md) | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | Jun 26, 2024 | SESE | | [K240910](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K240910.md) | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | Jun 12, 2024 | SESE | | [K241344](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K241344.md) | MetriCide™ OPA Plus Solution Test Strip | Steris | Jun 11, 2024 | SESE | | [DEN230068](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/DEN230068.md) | 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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K240032.md) | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | Apr 17, 2024 | SESE | | [K240760](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K240760.md) | CELERITY HP Indicator Tape | Steris | Apr 10, 2024 | SESE | | [K233654](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K233654.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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