Cleared Traditional

K042450 - STERRAD NX CHALLENGE PACK

K042450 is the FDA 510(k) clearance for STERRAD NX CHALLENGE PACK by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K042450 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
245d
Days
Class 2
Risk

K042450 is an FDA 510(k) clearance for the STERRAD NX CHALLENGE PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on May 12, 2005 after a review of 245 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

Submission Details

510(k) Number K042450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2004
Decision Date May 12, 2005
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 114
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K042450.
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · Advanced Sterilization Products · May 2007
STERRAD STERILIZER CYCLESURE TEST PACK
K051643 · Advanced Sterilization Products · Aug 2005
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
K052128 · 3M Company · Aug 2005
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · 3M Company · Oct 2003
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K031226 · Advanced Sterilization Products · May 2003
3M ATTEST 290 AUTO-READER
K004009 · 3M Company · Mar 2002