Cleared Traditional

K760997 - UNDER BOTTOCKS DRAPE

K760997 is the FDA 510(k) clearance for UNDER BOTTOCKS DRAPE by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K760997 · C.R. Bard, Inc. · General Hospital
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Mar 1977
Decision
135d
Days
Class 2
Risk

K760997 is an FDA 510(k) clearance for the UNDER BOTTOCKS DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1977 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K760997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1976
Decision Date March 23, 1977
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 145
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K760997.
HYPERALIMENTATION TRAY
K771050 · American Hospital Supply Corp. · Jul 1977
SURGICAL HEAD DRAPE, DISP.
K771136 · Procter & Gamble Mfg. Co. · Jul 1977
BARRIER O.B. PACK IV
K770560 · Surgikos, Inc. · Apr 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