Cleared Traditional

K151971 - STERRAD CYCLESURE 24 Biological Indicator

K151971 is an FDA 510(k) clearance for STERRAD CYCLESURE 24 Biological Indicator, 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 105-day FDA review.

K151971 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
105d
Days
Class 2
Risk

K151971 is an FDA 510(k) clearance for the STERRAD CYCLESURE 24 Biological Indicator. 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 October 29, 2015 after a review of 105 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K151971

510(k) Number K151971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date October 29, 2015
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 196
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K151971.
BCR-30-min BI™ and RBIP-ST30™ Readout Accessory
K151482 · Bcr Diagnostics, Inc. · Feb 2016
3M Attest Rapid Readout Biological Indicator 1295
K152060 · 3M Company · Dec 2015
Andersen EOGas 4 SteriTest
K151585 · Andersen Sterilizers, Inc. · Nov 2015
STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
K141580 · Tso3, Inc. · Dec 2014
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
K140589 · Mesa Laboratories, Inc. · Dec 2014
STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
K141238 · Sterilucent, Inc. · Nov 2014
K151971 · STERRAD CYCLESURE 24 Biological Indicator
Download PDF FDA Summary Advanced Sterilizatio…