Cleared Traditional

K092755 - STERRAAD 100NX EXPRESS CYCLE TEST PACK

K092755 is an FDA 510(k) clearance for STERRAAD 100NX EXPRESS CYCLE 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 534-day FDA review.

K092755 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
534d
Days
Class 2
Risk

K092755 is an FDA 510(k) clearance for the STERRAAD 100NX EXPRESS CYCLE 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 February 25, 2011 after a review of 534 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Advanced Sterilization Products devices

FDA 510(k) Submission Details - K092755

510(k) Number K092755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date February 25, 2011
Days to Decision 534 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
405d slower than avg
Panel avg: 129d · This submission: 534d
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 171
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K092755.
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
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K111150 · Steritec Products Mfg Co, Inc. · Jul 2011
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR
K103277 · 3M Company-3M Health Care · Apr 2011
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
K103321 · Dana Products, Inc. · Feb 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · Advanced Sterilization Products · Jan 2011