Cleared Traditional

K792176 - DRAPE, MICROSCOPE

K792176 is an FDA 510(k) clearance for DRAPE, manufactured by Chris Co., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K792176 · Chris Co., Inc. · General Hospital
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Dec 1979
Decision
40d
Days
Class 2
Risk

K792176 is an FDA 510(k) clearance for the DRAPE, MICROSCOPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Chris Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1979 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Chris Co., Inc. devices

FDA 510(k) Submission Details - K792176

510(k) Number K792176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1979
Decision Date December 10, 1979
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 299
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K792176.
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
K800552 · Carl Zeiss, Inc. · Mar 1980
STERILIZATION PROCESS CHANGE BOUNDARY
K792621 · Procter & Gamble Mfg. Co. · Jan 1980
STERILIZATION PROCESS/ABSORBENT TOWEL
K792623 · Procter & Gamble Mfg. Co. · Jan 1980
INSTRUMENT PAD
K791864 · Procter & Gamble Mfg. Co. · Oct 1979
BARRIER & FACE MASK WITH INNER FACING
K791719 · Surgikos, Inc. · Oct 1979
BARRIER* C-ARM DRAPE
K791438 · Surgikos, Inc. · Aug 1979