Cleared Traditional

LUMBO-SACRAL FLEXION ORTHOSIS (K811494) - FDA 510(k) Clearance

Class I Physical Medicine device.

K811494 · Surgical Appliance Industries, Inc. · Physical Medicine device
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Jun 1981
Decision
20d
Days
Class 1
Risk

K811494 is an FDA 510(k) clearance for the LUMBO-SACRAL FLEXION ORTHOSIS. Classified as Orthosis, Lumbo-sacral (product code IPY), Class I - General Controls.

Submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - 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 Surgical Appliance Industries, Inc. devices

Submission Details

510(k) Number K811494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1981
Decision Date June 16, 1981
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPY Orthosis, Lumbo-sacral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
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.