Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JOJ — Predicate Candidate Screening
264 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
301 days90th percentile
264clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026-02-20 | 30 | 0 |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013 | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 | 179 | 0 |
| K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025-06-03 | 61 | 0 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = | STERIS Corporation | 2025-05-02 | 29 | 0 |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | 2025-04-25 | 128 | 0 |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 | 30 | 0 |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | 2025-01-17 | 119 | 0 |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 | 245 | 0 |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024-12-04 | 26 | 0 |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 | 29 | 0 |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Steriliz | Kem Medical Products Corporation | 2024-09-30 | 97 | 0 |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024-08-20 | 26 | 0 |
| K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEA | Advanced Sterilization Products, Inc. | 2024-07-05 | 196 | 0 |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024-06-26 | 264 | 0 |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024-06-12 | 71 | 0 |
| K241344 | MetriCide™ OPA Plus Solution Test Strip | Steris | 2024-06-11 | 29 | 0 |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024-04-17 | 104 | 0 |
| K240760 | CELERITY HP Indicator Tape | Steris | 2024-04-10 | 21 | 0 |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo | Steris | 2023-12-08 | 24 | 0 |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (P | Steris | 2023-10-27 | 29 | 0 |
| K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable | Steris | 2023-08-07 | 76 | 0 |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation | 2023-07-17 | 139 | 0 |
| K222137 | OK Plus Indicator | Propper Manufacturing Co., Inc. | 2022-12-05 | 139 | 0 |
| K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022-12-02 | 260 | 0 |
| K222508 | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2022-11-01 | 75 | 0 |
| K222152 | 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2022-09-23 | 65 | 0 |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, | 3M Company | 2022-06-24 | 85 | 2 |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lea | 3M Company | 2022-05-23 | 84 | 0 |
| K213412 | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating | Steris Corparation | 2022-01-21 | 94 | 0 |
| K212592 | Gas-Chex Indicator | Propper Manufacturing Co., Inc. | 2022-01-20 | 157 | 0 |
| K212081 | 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2021-09-05 | 65 | 0 |
| K200096 | Crosstex VH2O2 Chemical Indicators | Crosstex International, Inc. (A Cantel Medical Company) | 2021-07-15 | 546 | 0 |
| K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021-06-21 | 90 | 0 |
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021-05-19 | 83 | 0 |
| K203458 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2020-12-11 | 17 | 0 |
| K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2020-12-10 | 31 | 0 |
| K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corporation | 2020-12-02 | 89 | 0 |
| K200334 | AN1036 Dosimeter | Andersen Sterilizers, Inc. | 2020-11-12 | 275 | 0 |
| K200272 | Terragene Chemdye | Terragene S.A. | 2020-06-30 | 147 | 0 |
| K200252 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg Co, Inc. | 2020-05-21 | 108 | 0 |
| K192445 | QwikCheck Chemical Indicators | Serim Research Corporation | 2020-04-02 | 209 | 0 |
| K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019-12-23 | 27 | 0 |
| K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | 2019-11-22 | 198 | 0 |
| K192937 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019-11-16 | 29 | 0 |
| K192673 | 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2019-10-28 | 32 | 0 |
| K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | 2019-10-21 | 87 | 0 |
| K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Pro | STERIS Corporation | 2019-09-05 | 38 | 0 |
| K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Ste | Intertape Polymer, Inc. | 2019-08-02 | 32 | 0 |
| K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | 2019-03-01 | 239 | 0 |
| K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019-02-26 | 99 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda