Cleared Traditional

K891784 - BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR

K891784 is an FDA 510(k) clearance for BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR, manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K891784 · Propper Mfg. Co., Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1990
Decision
322d
Days
Class 2
Risk

K891784 is an FDA 510(k) clearance for the BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K891784

510(k) Number K891784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date February 09, 1990
Days to Decision 322 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
193d slower than avg
Panel avg: 129d · This submission: 322d
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 131
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K891784.
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992
BI-O.K. STEAM TEST-PAK
K903024 · Propper Mfg. Co., Inc. · Sep 1990
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
SPORVIEW CULTURE MEDIA
K890754 · Spsmedical Supply Corp. · Nov 1989
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986
CHEMSPOR
K844479 · American Sterilizer Co. · Nov 1985