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 |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 |
| 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 |
| DEN230068 | 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 | 3M Company | 2024-05-21 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D771604231 | Dental City | ICP, INC. | 2026-05-27 |
| D771603531 | Dental City | ICP, INC. | 2026-05-27 |
| D771604391 | Dental City | ICP, INC. | 2026-05-27 |
| D771604291 | Dental City | ICP, INC. | 2026-05-27 |
| D771604281 | Dental City | ICP, INC. | 2026-05-27 |
| D771604271 | Dental City | ICP, INC. | 2026-05-27 |
| D771604251 | Dental City | ICP, INC. | 2026-05-27 |
| 07798164672173 | Chemdye® | TERRAGENE S.A. | 2022-03-24 |
| 07798164673705 | Chemdye® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677703 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677680 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677406 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677390 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164671176 | Integron® | TERRAGENE S.A. | 2022-03-22 |
| 07798164675600 | Integron® | TERRAGENE S.A. | 2022-03-22 |
| 07798164676287 | Chemdye® | TERRAGENE S.A. | 2022-03-22 |
| 07798164677864 | Chemdye® | TERRAGENE S.A. | 2022-03-21 |
| 07798164677857 | Chemdye® | TERRAGENE S.A. | 2022-03-21 |
| 07798164677376 | Tuttnauer® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675969 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675952 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675624 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675617 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675556 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675525 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164672319 | Integron® | TERRAGENE S.A. | 2022-03-21 |
| 07798164676027 | Bionova® | TERRAGENE S.A. | 2022-02-01 |
| 07798164675976 | Bionova® | TERRAGENE S.A. | 2022-01-17 |
| 07798164675846 | Integron® | TERRAGENE S.A. | 2022-01-17 |
| 07798164672890 | Chemdye® | TERRAGENE S.A. | 2021-01-08 |