Cleared Traditional

K855101 - ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR

K855101 is an FDA 510(k) clearance for ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR, manufactured by Surgicot, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K855101 · Surgicot, Inc. · General Hospital
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Jul 1986
Decision
206d
Days
Class 2
Risk

K855101 is an FDA 510(k) clearance for the ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR. 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 July 17, 1986 after a review of 206 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

FDA 510(k) Submission Details - K855101

510(k) Number K855101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date July 17, 1986
Days to Decision 206 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 129d · This submission: 206d
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 151
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K855101.
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.
K894399 · Pymah Corp. · Sep 1989
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)
K891366 · Mdt Corp., Inc. · Mar 1989
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K863122 · Surgicot, Inc. · Dec 1986
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986
ASSERT EO BIOLOGICAL TEST PACK
K854631 · Surgicot, Inc. · May 1986
SURGICOT STEAM TEST PACK
K854902 · Surgicot, Inc. · May 1986