Cleared Traditional

K103218 - STERRAD CHEMICAL INDICATOR STRIP

K103218 is an FDA 510(k) clearance for STERRAD CHEMICAL INDICATOR STRIP, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K103218 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
151d
Days
Class 2
Risk

K103218 is an FDA 510(k) clearance for the STERRAD CHEMICAL INDICATOR STRIP. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on April 1, 2011 after a review of 151 days - an extended review cycle.

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 Advanced Sterilization Products devices

FDA 510(k) Submission Details - K103218

510(k) Number K103218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date April 01, 2011
Days to Decision 151 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
22d slower than avg
Panel avg: 129d · This submission: 151d
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 212
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K103218.
INDISTRIP GREEN
K110369 · Indilab, Inc. · May 2011
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
K110253 · Dana Products, Inc. · Apr 2011
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
K110152 · Spsmedical Supply Corp. · Apr 2011
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219 · Advanced Sterilization Products · Apr 2011
VERIFY 270FP CHALLENGE PACK
K103053 · STERIS Corporation · Mar 2011
SMART READ BIOLOGICAL TEST PACK
K103000 · Steritec Products Mfg Co, Inc. · Feb 2011