Cleared Traditional

K854631 - ASSERT EO BIOLOGICAL TEST PACK

K854631 is the FDA 510(k) clearance for ASSERT EO BIOLOGICAL TEST PACK by Surgicot, Inc.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K854631 · Surgicot, Inc. · General Hospital
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May 1986
Decision
190d
Days
Class 2
Risk

K854631 is an FDA 510(k) clearance for the ASSERT EO BIOLOGICAL TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Surgicot, Inc. (Smithtown, US). The FDA issued a Cleared decision on May 27, 1986 after a review of 190 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 Surgicot, Inc. devices

Submission Details

510(k) Number K854631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date May 27, 1986
Days to Decision 190 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 129d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K854631.
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · 3M Company · Oct 2003
3M ATTEST 290 AUTO-READER
K004009 · 3M Company · Mar 2002
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
TRAVASPORE BIOLOGICAL INDICATOR
K832922 · Travenol Laboratories, S.A. · Nov 1983
BACILLUM PUMILUS SPORE STRIPS
K810930 · Oxoid U.S.A., Inc. · Jun 1981