Cleared Traditional

K071537 - STERRAD 100NX TEST PACK

K071537 is an FDA 510(k) clearance for STERRAD 100NX TEST 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 196-day FDA review.

K071537 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
196d
Days
Class 2
Risk

K071537 is an FDA 510(k) clearance for the STERRAD 100NX TEST 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 December 18, 2007 after a review of 196 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 - K071537

510(k) Number K071537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date December 18, 2007
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 K071537.
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES
K090514 · STERIS Corporation · Mar 2009
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
K073618 · STERIS Corporation · Jan 2009
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES
K073244 · STERIS Corporation · May 2008
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
K070595 · Spsmedical Supply Corp. · May 2007
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · Advanced Sterilization Products · May 2007
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
K051056 · Albert Browne , Ltd. · Oct 2005