Product code JOJ
- Device name
- Indicator, Physical/Chemical Sterilization Process
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2800
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026-02-20 |
| 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. | 2025-12-23 |
| K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025-06-03 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025-05-02 |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | 2025-04-25 |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | 2025-01-17 |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024-12-04 |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | 2024-09-30 |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024-08-20 |
| 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); ... | Advanced Sterilization Products, Inc. | 2024-07-05 |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024-06-26 |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024-06-12 |
| K241344 | MetriCide™ OPA Plus Solution Test Strip | Steris | 2024-06-11 |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024-04-17 |
| K240760 | CELERITY HP Indicator Tape | Steris | 2024-04-10 |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Steris | 2023-12-08 |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris | 2023-10-27 |
| K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | Steris | 2023-08-07 |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation | 2023-07-17 |
| K222137 | OK Plus Indicator | Propper Manufacturing Co., Inc. | 2022-12-05 |
| K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022-12-02 |
| K222508 | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2022-11-01 |
| K222152 | 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2022-09-23 |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022-06-24 |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | 3M Company | 2022-05-23 |
| K213412 | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM | Steris Corparation | 2022-01-21 |
| K212592 | Gas-Chex Indicator | Propper Manufacturing Co., Inc. | 2022-01-20 |
| K212081 | 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2021-09-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00724995362973 | VERIFY | ALBERT BROWNE LIMITED | 2026-07-16 |
| 30818087011618 | Propper Vapor Line Integrators | PROPPER MANUFACTURING COMPANY, INC. | 2026-07-16 |
| 00840456206881 | JMU | JMU DENTAL, INC | 2026-07-08 |
| 00840456206898 | JMU | JMU DENTAL, INC | 2026-07-08 |
| 00840456206928 | JMU | JMU DENTAL, INC | 2026-07-08 |
| 00840456201312 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201282 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201831 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201848 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201855 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201862 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201879 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201886 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201893 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201909 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201916 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201923 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201930 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201305 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201299 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201275 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201077 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201060 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456201053 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 09350855000542 | trophon Chemical Indicator | NANOSONICS LIMITED | 2022-05-12 |
| 09350855000177 | trophon Chemical Indicator | NANOSONICS LIMITED | 2018-06-15 |
| 10705037016198 | STERRAD™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 05055049007423 | AESCULAP | AESCULAP, INC. | 2016-09-22 |
| 09350855000047 | Trophon Chemical Indicator | NANOSONICS LIMITED | 2016-09-21 |
| 09350855000054 | Trophon Chemical Indicator | NANOSONICS LIMITED | 2016-09-21 |