Cleared Traditional

K051056 - VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR

K051056 is an FDA 510(k) clearance for VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR, manufactured by Albert Browne , Ltd.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K051056 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
177d
Days
Class 2
Risk

K051056 is an FDA 510(k) clearance for the VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Albert Browne , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 177 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 Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K051056

510(k) Number K051056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date October 20, 2005
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 147
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K051056.
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K051643 · Advanced Sterilization Products · Aug 2005
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
K052128 · 3M Company · Aug 2005
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