Cleared Traditional

LIMB ORTHOSIS (K810443) - FDA 510(k) Clearance

Class I Physical Medicine device.

K810443 · Fred Sammons, Inc. · Physical Medicine device
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Mar 1981
Decision
13d
Days
Class 1
Risk

K810443 is an FDA 510(k) clearance for the LIMB ORTHOSIS. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 13 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 K810443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1981
Decision Date March 04, 1981
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQI Orthosis, Limb Brace
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 - IQI Orthosis, Limb Brace

All 15
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K810443.
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981
BAUER & BLACK RIGID WRIST BRACE
K801701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708 · Fred Sammons, Inc. · Aug 1980
SECUTE ELBOW BAND
K791248 · Conphar, Inc. · Jul 1979