Product code JOJ: 510(k) clearances and predicates
Product code JOJ covers 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES). FDA lists 265 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
265 clearances on file under product code JOJ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 4 |
| 2024 | 11 |
| 2025 | 6 |
| 2026 so far | 2 |
Recent clearances
Newest JOJ clearances in the FDA index, with applicant and decision date:
- K261992, 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES), applicant Solventum US, LLC, decided 2026-09-25. FDA record
- K260181, LF Process Indicator Tape for Steam Sterilization, applicant Intertape Polymer Group, decided 2026-02-20. FDA record
- K251991, SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213), applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd., decided 2025-12-23. FDA record
- K251035, DISINTEK PA Test Strips, applicant Serim Research, decided 2025-06-03. FDA record
- K251048, Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118, applicant STERIS Corporation, decided 2025-05-02. FDA record
- K243876, VERIFY STEAM Integrating Indicator, applicant STERIS Corporation, decided 2025-04-25. FDA record
- K250172, Green Card Bowie-Dick Test (BD115), applicant Steritec Products, Inc. (A Getinge Company), decided 2025-02-20. FDA record
- K242860, Type 5 Integrating Indicator for Steam (CSPN-15), applicant True Indicating, LLC, decided 2025-01-17. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include LF Process Indicator Tape for Steam Sterilization, SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213). Watch new JOJ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JOJ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JOJ clearances include 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES).
How many 510(k) clearances use product code JOJ?
265 at the time this page was generated, from openFDA records.
How do I find a predicate device under JOJ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JOJ clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.