Cleared Traditional

K801436 - ORTHOPEDIC LOWER EXTREMITY SUSPENSION (FDA 510(k) Clearance)

Class I General Hospital device.

K801436 · Orthopedic Systems, Inc. · General Hospital
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Jun 1980
Decision
7d
Days
Class 1
Risk

K801436 is an FDA 510(k) clearance for the ORTHOPEDIC LOWER EXTREMITY SUSPENSION. Classified as Splint, Extremity, Noninflatable, External, Sterile (product code FYH), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.3910 - the FDA general hospital 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 Orthopedic Systems, Inc. devices

Submission Details

510(k) Number K801436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1980
Decision Date June 26, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 128d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYH Splint, Extremity, Noninflatable, External, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3910
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.