Cleared Traditional

K822024 - BACILLU S SUBTILIS BIOLOGICAL INDICA.

K822024 is an FDA 510(k) clearance for BACILLU S SUBTILIS BIOLOGICAL INDICA., manufactured by Findley Research, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K822024 · Findley Research, Inc. · General Hospital
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Jul 1982
Decision
13d
Days
Class 2
Risk

K822024 is an FDA 510(k) clearance for the BACILLU S SUBTILIS BIOLOGICAL INDICA.. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Findley Research, Inc. (Walker, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 13 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Findley Research, Inc. devices

FDA 510(k) Submission Details - K822024

510(k) Number K822024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1982
Decision Date July 22, 1982
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 186
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K822024.
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · Parke-Davis Co. · Nov 1985
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
K850144 · American Sterilizer Co. · Jun 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
STEAROTHERMOHILUS SPORE STRIPS
K800482 · Mdt Corp., Inc. · Apr 1980