Cleared Traditional

K792648 - UNILAB CULTURING SET

K792648 is an FDA 510(k) clearance for UNILAB CULTURING SET, manufactured by Sybron Corp.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K792648 · Sybron Corp. · General Hospital
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Feb 1980
Decision
47d
Days
Class 2
Risk

K792648 is an FDA 510(k) clearance for the UNILAB CULTURING SET. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Sybron Corp. (Mchenry, US). The FDA issued a Cleared decision on February 6, 1980 after a review of 47 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 Sybron Corp. devices

FDA 510(k) Submission Details - K792648

510(k) Number K792648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1979
Decision Date February 06, 1980
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 184
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K792648.
BACILLUM PUMILUS SPORE STRIPS
K810930 · Oxoid U.S.A., Inc. · Jun 1981
STEAROTHERMOHILUS SPORE STRIPS
K800482 · Mdt Corp., Inc. · Apr 1980
SURGICOT 2 INDICATOR SYSTEM
K800029 · Surgicot, Inc. · Mar 1980
UNISPORE-BIOLOGICAL INDICATORS
K792649 · Castle Co. · Jan 1980
MONITOR, AERATION, TEC-TEST
K770953 · Castle Co. · Jul 1977
MARKET CASTLE UNISPHERE
K761015 · Castle Co. · Jan 1977