Cleared Traditional

K770396 - DRAPES

K770396 is an FDA 510(k) clearance for DRAPES, manufactured by Mark One Healthcare Products. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K770396 · Mark One Healthcare Products · General Hospital
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Mar 1977
Decision
22d
Days
Class 2
Risk

K770396 is an FDA 510(k) clearance for the DRAPES, MODESTY. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Mark One Healthcare Products (Mchenry, US). The FDA issued a Cleared decision on March 23, 1977 after a review of 22 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 Mark One Healthcare Products devices

FDA 510(k) Submission Details - K770396

510(k) Number K770396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1977
Decision Date March 23, 1977
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 194
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K770396.
SURGICAL HEAD DRAPE, DISP.
K771136 · Procter & Gamble Mfg. Co. · Jul 1977
BARRIER O.B. PACK IV
K770560 · Surgikos, Inc. · Apr 1977
UNDER BOTTOCKS DRAPE
K760997 · C.R. Bard, Inc. · Mar 1977
BARRIER IMPERVIOUS BACK TABLE COVER
K761204 · Surgikos, Inc. · Jan 1977
BARRIER NEURO SHEET
K760937 · Surgikos, Inc. · Dec 1976
BARRIER IMPERVIOUS S-OCKINETTE
K760890 · Surgikos, Inc. · Nov 1976