Cleared Traditional

K850144 - BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH

K850144 is an FDA 510(k) clearance for BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH, manufactured by American Sterilizer Co.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K850144 · American Sterilizer Co. · General Hospital
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Jun 1985
Decision
154d
Days
Class 2
Risk

K850144 is an FDA 510(k) clearance for the BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on June 17, 1985 after a review of 154 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 American Sterilizer Co. devices

FDA 510(k) Submission Details - K850144

510(k) Number K850144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date June 17, 1985
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
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 127
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K850144.
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986
CHEMSPOR
K844479 · American Sterilizer Co. · Nov 1985
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · Parke-Davis Co. · Nov 1985
TRAVASPORE BIOLOGICAL INDICATOR
K832922 · Travenol Laboratories, S.A. · Nov 1983
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K812272 · Sybron Corp. · Sep 1981
BACILLUM PUMILUS SPORE STRIPS
K810930 · Oxoid U.S.A., Inc. · Jun 1981