Cleared Traditional

K903024 - BI-O.K. STEAM TEST-PAK

K903024 is an FDA 510(k) clearance for BI-O.K. STEAM TEST-PAK, 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 64-day FDA review.

K903024 · Propper Mfg. Co., Inc. · General Hospital
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Sep 1990
Decision
64d
Days
Class 2
Risk

K903024 is an FDA 510(k) clearance for the BI-O.K. STEAM TEST-PAK. 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 September 12, 1990 after a review of 64 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 Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K903024

510(k) Number K903024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1990
Decision Date September 12, 1990
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 K903024.
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995
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K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
K891784 · Propper Mfg. Co., Inc. · Feb 1990
SPORVIEW CULTURE MEDIA
K890754 · Spsmedical Supply Corp. · Nov 1989