3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)— 510(k) K261992
Substantially EquivalentSolventum US, LLC
FDA 510(k) clearance K261992 for 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES), Substantially Equivalent on 2026-09-25. Applicant: Solventum US, LLC. Device class: 2.
Summary
The 3M Attest Steam Chemical Integrator comes in four catalog versions: 1243A, 1243B, 1243RE, and 1243RES. It's filed under JOJ, physical and chemical sterilization process indicators. The name says it's for steam sterilization.
Class II, 21 CFR 880.2800. The General Hospital panel reviewed it as a Traditional 510(k).
The applicant is Solventum US, LLC, filing from San Antonio, Texas. The record doesn't explain the 3M branding on a Solventum filing. Review took 102 days (June 15 to September 25, 2026).
Clearance details
- Applicant
- Solventum US, LLC
- Product code
- Product code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
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view allData sourced from openFDA. This site is unofficial and independent of the FDA.