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The Tracker / September 2026 / K261992

510(k) cleared

3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

Solventum US, LLC · Sep 25, 2026 · K261992

FDA cleared the 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) from Solventum US, LLC on Sep 25, 2026 under K261992, a traditional 510(k). The device falls under product code JOJ, Indicator, Physical/Chemical Sterilization Process, regulated at 21 CFR 880.2800 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 15, 2026. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Solventum US, LLC has one other decision in the tracker over the last 12 months: K251866 (Tegaderm Post-Op Transparent Antimicrobial Dressing).

Questions & Answers

What did FDA clear under K261992?

K261992 is the FDA 510(k) for 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES), submitted by Solventum US, LLC. FDA's decision date was Sep 25, 2026, under product code JOJ (Indicator, Physical/Chemical Sterilization Process).

Who makes the 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

Solventum US, LLC, based in San Antonio, TX, is the applicant of record for K261992.

How long did the K261992 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Sep 25, 2026, 102 days later.

← All decisions in September 2026

Sources