Cleared Traditional

K802673 - KNEE BRACE/STABILIZER

K802673 is an FDA 510(k) clearance for KNEE BRACE/STABILIZER, manufactured by Omni Scientific, Inc.. The device is a Class 1 Physical Medicine device with product code ITQ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K802673 · Omni Scientific, Inc. · Physical Medicine device
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Nov 1980
Decision
16d
Days
Class 1
Risk

K802673 is an FDA 510(k) clearance for the KNEE BRACE/STABILIZER. Classified as Joint, Knee, External Brace (product code ITQ), Class I - General Controls.

Submitted by Omni Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 16 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 - K802673

510(k) Number K802673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1980
Decision Date November 12, 1980
Days to Decision 16 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
100d faster than avg
Panel avg: 116d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

ITQ Device Classification - Class 1, General Controls

Product Code ITQ Joint, Knee, External 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 - ITQ Joint, Knee, External Brace

All 14
Devices cleared under the same product code (ITQ) and FDA review panel - the closest regulatory comparables to K802673.
AIRCAST PNEUMATIC KNEE BRACE
K812094 · Aircast, Inc. · Aug 1981
CYLINDER KNEE CAST/SPLINT
K811689 · Surgical Appliance Industries, Inc. · Jun 1981
LIMB ORHTOSIS
K810222 · Medical Design & Manufacturing Corp. · Feb 1981
FRACTURE BRACING
K780892 · Hosmer Dorrance Corp. · Jun 1978
DEMI-WALKER (REGULAR)
K772268 · Med Fusion Systems, Inc. · Dec 1977
SETUP WALKER ADJUSTABLE
K772269 · Med Fusion Systems, Inc. · Dec 1977
K802673 · KNEE BRACE/STABILIZER
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