Cleared Traditional

K042450 - STERRAD NX CHALLENGE PACK

K042450 is an FDA 510(k) clearance for STERRAD NX CHALLENGE PACK, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K042450

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.

FRC Device Classification - Class 2, Special Controls

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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K042450.
STERRAD STERILIZER CYCLESURE TEST PACK
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3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
K052128 · 3M Company · Aug 2005
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
K051173 · Spsmedical Supply Corp. · May 2005
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
K050664 · Getinge USA, Inc. · Apr 2005
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
K050591 · Raven Biological Laboratories, Inc. · Mar 2005
RAVEN PROTEST - EO
K041784 · Raven Biological Laboratories, Inc. · Sep 2004