Cleared Traditional

K051643 - STERRAD STERILIZER CYCLESURE TEST PACK

K051643 is an FDA 510(k) clearance for STERRAD STERILIZER CYCLESURE 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 60-day FDA review.

K051643 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
60d
Days
Class 2
Risk

K051643 is an FDA 510(k) clearance for the STERRAD STERILIZER CYCLESURE 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 August 19, 2005 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Sterilization Products devices

FDA 510(k) Submission Details - K051643

510(k) Number K051643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2005
Decision Date August 19, 2005
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K051643.
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
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
STERRAD NX CHALLENGE PACK
K042450 · Advanced Sterilization Products · May 2005