Cleared Traditional

VELCRO FINGER/TOE SPLINT (K812654) - FDA 510(k) Clearance

Class I Physical Medicine device.

K812654 · Maddak, Inc. · Physical Medicine device
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Sep 1981
Decision
8d
Days
Class 1
Risk

K812654 is an FDA 510(k) clearance for the VELCRO FINGER/TOE SPLINT. Classified as Splint, Hand, And Components (product code ILH), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 25, 1981 after a review of 8 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.

View all Maddak, Inc. devices

Submission Details

510(k) Number K812654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1981
Decision Date September 25, 1981
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILH Splint, Hand, And Components
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 - ILH Splint, Hand, And Components

All 35
Devices cleared under the same product code (ILH) and FDA review panel - the closest regulatory comparables to K812654.
SPLINTS
K831548 · Fred Sammons, Inc. · Jun 1983
FINGER FLEXION SPLINT
K823644 · Fred Sammons, Inc. · Jan 1983
FINGER EXTENSION SPLINT
K823647 · Fred Sammons, Inc. · Jan 1983
WRIST SUPPORT
K823601 · Fred Sammons, Inc. · Dec 1982
SOFT ULNAR DEVIATION SPLINTS
K821635 · Fred Sammons, Inc. · Jun 1982
WIRE-FOAM MP FLEXION SPRING
K821637 · Fred Sammons, Inc. · Jun 1982