Cleared Traditional

K780867 - PAD HOLDER KIT

K780867 is an FDA 510(k) clearance for PAD HOLDER KIT, manufactured by Devon Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSE cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K780867 · Devon Industries, Inc. · General & Plastic Surgery device
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Aug 1978
Decision
76d
Days
Class 1
Risk

K780867 is an FDA 510(k) clearance for the PAD HOLDER KIT. Classified as Table, Operating-room, Manual (product code FSE), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery 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 - K780867

510(k) Number K780867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1978
Decision Date August 14, 1978
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

FSE Device Classification - Class 1, General Controls

Product Code FSE Table, Operating-room, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FSE Table, Operating-room, Manual

Devices cleared under the same product code (FSE) and FDA review panel - the closest regulatory comparables to K780867.
CHEMONUCLEOLYSIS TABLE EXTENSION
K831042 · Orthopedic Systems, Inc. · May 1983
ARMBOARD CVER, DISPOSABLE
K782092 · Anago, Inc. · Jan 1979
CHEST ROLLS HOLDER
K780866 · Devon Industries, Inc. · Aug 1978
CHEST ROLLS
K780868 · Devon Industries, Inc. · Aug 1978
I.V. SUPPORT, TECNOL ARMBOARD
K760308 · Tecnol New Jersey Wound Care, Inc. · Aug 1976