Cleared Traditional

K120435 - BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR

K120435 is an FDA 510(k) clearance for BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K120435 · STERIS Corporation · General Hospital
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Jun 2012
Decision
112d
Days
Class 2
Risk

K120435 is an FDA 510(k) clearance for the BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on June 4, 2012 after a review of 112 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 STERIS Corporation devices

FDA 510(k) Submission Details - K120435

510(k) Number K120435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date June 04, 2012
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 204
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K120435.
RAPICIDE OPA-28 TEST STRIP
K120652 · Serim Research Corp. · Oct 2012
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518 · Advanced Sterilization Products · Oct 2012
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
K111519 · Advanced Sterilization Products · Oct 2012
STEAM DOT BLU PROCESS INDICATOR
K111453 · Propper Mfg. Co., Inc. · Apr 2012
STERIS STEAM PI
K112256 · STERIS Corporation · Jan 2012
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
K103331 · STERIS Corporation · Sep 2011