Cleared Traditional

K972747 - BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305

K972747 is an FDA 510(k) clearance for BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305, 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 170-day FDA review.

K972747 · Propper Mfg. Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
170d
Days
Class 2
Risk

K972747 is an FDA 510(k) clearance for the BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320). Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 170 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 Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K972747

510(k) Number K972747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1997
Decision Date January 09, 1998
Days to Decision 170 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 129d · This submission: 170d
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 130
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K972747.
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
K991618 · Propper Mfg. Co., Inc. · Jan 2001
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · Advanced Sterilization Products · Jun 1999
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995
STERRAD BI TEST PACK
K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992