Cleared Special

K040742 - MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE

K040742 is an FDA 510(k) clearance for MODIFICATION TO STERRAD SEALSURE CHEMIC..., manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code JOJ cleared through the Special 510(k) pathway after a 10-day FDA review.

K040742 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
10d
Days
Class 2
Risk

K040742 is an FDA 510(k) clearance for the MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE. 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 2, 2004 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Sterilization Products devices

FDA 510(k) Submission Details - K040742

510(k) Number K040742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2004
Decision Date April 02, 2004
Days to Decision 10 days
Submission Type Special
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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

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 217
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K040742.
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · Propper Mfg. Co., Inc. · Aug 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · Spsmedical Supply Corp. · Jun 2004
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K032801 · Albert Browne , Ltd. · Oct 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · Spsmedical Supply Corp. · May 2003
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · Advanced Sterilization Products · Oct 2002