Cleared Traditional

K780612 - STOCKINETTE, STERILE

K780612 is an FDA 510(k) clearance for STOCKINETTE, manufactured by Abco Dealers, Inc.. The device is a Class 1 Physical Medicine device with product code ILG cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K780612 · Abco Dealers, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1978
Decision
9d
Days
Class 1
Risk

K780612 is an FDA 510(k) clearance for the STOCKINETTE, STERILE. Classified as Stocking, Elastic (product code ILG), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K780612

510(k) Number K780612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date April 19, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 116d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

ILG Device Classification - Class 1, General Controls

Product Code ILG Stocking, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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 - ILG Stocking, Elastic

All 7
Devices cleared under the same product code (ILG) and FDA review panel - the closest regulatory comparables to K780612.
ORTHOPEDIC STOCKINETTE
K833437 · Northern Medical Surgical, Inc. · Nov 1983
COMPRESSOGRIP ELASTIC STUMP SHRINKER#
K831540 · Fred Sammons, Inc. · Jun 1983
STERILE ORTHOPEDIC STOCKINETTE
K780547 · Alba-Waldensian, Inc. · Apr 1978
ORTHOPEDIC STOCKINETTE
K770346 · Convertors · Mar 1977
STOCKINETTE
K770173 · Chase Mfg. Co. · Feb 1977
ORTHOPEDIC TUBULAR STOCKINETTE
K760817 · Parke-Davis Co. · Oct 1976
K780612 · STOCKINETTE, STERILE
Download PDF Abco Dealers, Inc.