Cleared Traditional

PLATFORM SPLINTS (K772411) - FDA 510(k) Clearance

Class I Physical Medicine device.

K772411 · Fred Sammons, Inc. · Physical Medicine device
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Jan 1978
Decision
9d
Days
Class 1
Risk

K772411 is an FDA 510(k) clearance for the PLATFORM SPLINTS. Classified as Splint, Hand, And Components (product code ILH), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 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.

View all Fred Sammons, Inc. devices

Submission Details

510(k) Number K772411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date January 05, 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 22
Devices cleared under the same product code (ILH) and FDA review panel - the closest regulatory comparables to K772411.
PLATFORM SPLINTS
K790180 · Fred Sammons, Inc. · Feb 1979
SOFT SPLINT STRAPS
K790181 · Fred Sammons, Inc. · Feb 1979
RESTING PAN SPLINTS
K772410 · Fred Sammons, Inc. · Jan 1978
PRE-FORMED SPLINT BLANKS
K772416 · Fred Sammons, Inc. · Jan 1978
SPLINTS, FINGER/TOE
K770786 · Depuy, Inc. · May 1977
SAFETY PIN SPLINT
K761131 · Fred Sammons, Inc. · Dec 1976