Cleared Traditional

K780865 - MAGNETIC DRAPE - INSTRUMENT HOLDER

K780865 is an FDA 510(k) clearance for MAGNETIC DRAPE - INSTRUMENT HOLDER, manufactured by Devon Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K780865 · Devon Industries, Inc. · General Hospital
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Aug 1978
Decision
83d
Days
Class 2
Risk

K780865 is an FDA 510(k) clearance for the MAGNETIC DRAPE - INSTRUMENT HOLDER. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1978 after a review of 83 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K780865

510(k) Number K780865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1978
Decision Date August 21, 1978
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 164
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K780865.
STOCKINETTE, DISPOSABLESURGICAL
K782091 · Anago, Inc. · Jan 1979
STOCKINETTE
K781944 · Kimberly-Clark Corp. · Dec 1978
U-DRAPE, BOUNDARY
K781172 · Procter & Gamble Mfg. Co. · Aug 1978
BARRIER PEDIATRIC/INCISE DRAPE 450
K780839 · Surgikos, Inc. · Aug 1978
BARRIER LAPAROTOMY SHEET 450
K780840 · Surgikos, Inc. · Aug 1978
BARRIER MEDIUM SHEET 450
K780841 · Surgikos, Inc. · Aug 1978