Cleared Traditional

K923739 - ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR

K923739 is an FDA 510(k) clearance for ABTOX SERILIZATION PROCESS BIOLOGICAL I..., manufactured by Abtox, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 878-day FDA review.

K923739 · Abtox, Inc. · General Hospital
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Dec 1994
Decision
878d
Days
Class 2
Risk

K923739 is an FDA 510(k) clearance for the ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Abtox, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 22, 1994 after a review of 878 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Abtox, Inc. devices

FDA 510(k) Submission Details - K923739

510(k) Number K923739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date December 22, 1994
Days to Decision 878 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
749d slower than avg
Panel avg: 129d · This submission: 878d
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 185
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