Cleared Traditional

K261992 - 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

K261992 is an FDA 510(k) clearance for 3M Attest Steam Chemical Integrator (1243A, manufactured by Solventum US, LLC. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K261992 · Solventum US, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
102d
Days
Class 2
Risk

K261992 is an FDA 510(k) clearance for the 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Solventum US, LLC (San Antonio, US). The FDA issued a Cleared decision on September 25, 2026 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Solventum US, LLC devices

FDA 510(k) Submission Details - K261992

510(k) Number K261992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2026
Decision Date September 25, 2026
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 240
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K261992.
LF Process Indicator Tape for Steam Sterilization
K260181 · Intertape Polymer Group · Feb 2026
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Dec 2025
DISINTEK™ PA Test Strips
K251035 · Serim Research · Jun 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · STERIS Corporation · May 2025
VERIFY STEAM Integrating Indicator
K243876 · STERIS Corporation · Apr 2025
Green Card Bowie-Dick Test (BD115)
K250172 · Steritec Products, Inc. (A Getinge Company) · Feb 2025