Cleared Traditional

ELASTIC COMPRESSION ANKLET (K823350) - FDA 510(k) Clearance

Class I General Hospital device.

K823350 · Podiatry Products Corp. · General Hospital
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Dec 1982
Decision
24d
Days
Class 1
Risk

K823350 is an FDA 510(k) clearance for the ELASTIC COMPRESSION ANKLET. Classified as Stocking, Medical Support (for General Medical Purposes) (product code FQL), Class I - General Controls.

Submitted by Podiatry Products Corp. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - 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 Podiatry Products Corp. devices

Submission Details

510(k) Number K823350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date December 03, 1982
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQL Stocking, Medical Support (for General Medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5780
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.