Cleared Abbreviated

K111453 - STEAM DOT BLU PROCESS INDICATOR

K111453 is an FDA 510(k) clearance for STEAM DOT BLU PROCESS INDICATOR, manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Abbreviated 510(k) pathway after a 316-day FDA review.

K111453 · Propper Mfg. Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
316d
Days
Class 2
Risk

K111453 is an FDA 510(k) clearance for the STEAM DOT BLU PROCESS INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island, US). The FDA issued a Cleared decision on April 5, 2012 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K111453

510(k) Number K111453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2011
Decision Date April 05, 2012
Days to Decision 316 days
Submission Type Abbreviated
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
187d slower than avg
Panel avg: 129d · This submission: 316d
Pathway characteristics
Standards-based clearance path.

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 163
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K111453.
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
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
K120435 · STERIS Corporation · Jun 2012
STERIS STEAM PI
K112256 · STERIS Corporation · Jan 2012
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
K103331 · STERIS Corporation · Sep 2011
CLASSIX CHEMICAL STERILIZATION INDICATOR
K102894 · Propper Mfg. Co., Inc. · May 2011