Cleared Traditional

K800029 - SURGICOT 2 INDICATOR SYSTEM

K800029 is an FDA 510(k) clearance for SURGICOT 2 INDICATOR SYSTEM, manufactured by Surgicot, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K800029 · Surgicot, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1980
Decision
65d
Days
Class 2
Risk

K800029 is an FDA 510(k) clearance for the SURGICOT 2 INDICATOR SYSTEM. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Surgicot, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 65 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 Surgicot, Inc. devices

FDA 510(k) Submission Details - K800029

510(k) Number K800029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1980
Decision Date March 12, 1980
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 151
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K800029.
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K812272 · Sybron Corp. · Sep 1981
BACILLUM PUMILUS SPORE STRIPS
K810930 · Oxoid U.S.A., Inc. · Jun 1981
STEAROTHERMOHILUS SPORE STRIPS
K800482 · Mdt Corp., Inc. · Apr 1980
UNILAB CULTURING SET
K792648 · Sybron Corp. · Feb 1980
UNISPORE-BIOLOGICAL INDICATORS
K792649 · Castle Co. · Jan 1980
MONITOR, AERATION, TEC-TEST
K770953 · Castle Co. · Jul 1977