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FDA 510(k)

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

K-Number: K261992 · 2026-09-25

ApplicantSolventum US, LLC
Decision Date2026-09-25
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) is the device name listed in this FDA 510(k) record. The listed applicant is Solventum US, LLC. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261992. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Solventum US, LLC. The 510(k) number is K261992.

When did 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) receive FDA 510(k) clearance?

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261992.

Who is the listed applicant for 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

The FDA 510(k) record lists Solventum US, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

The FDA product code for 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) is JOJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Solventum US, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure 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.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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