Cleared Traditional

K823819 - CAST TOE COVER

K823819 is an FDA 510(k) clearance for CAST TOE COVER, manufactured by Danek Medical, Inc.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K823819 · Danek Medical, Inc. · Orthopedic device
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Jan 1983
Decision
28d
Days
Class 1
Risk

K823819 is an FDA 510(k) clearance for the CAST TOE COVER. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Danek Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - the FDA orthopedic device regulatory 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K823819

510(k) Number K823819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1982
Decision Date January 14, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

LGF Device Classification - Class 1, General Controls

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
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 - LGF Component, Cast

All 9
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K823819.
COLORED CASTING TAPE (RED AND BLUE)
K870404 · Buckman Co., Inc. · Feb 1987
DELTA-LITE CASTING RESIN
K854554 · Johnson & Johnson Professionals, Inc. · Dec 1985
DELTA-LITE CASTING RESIN
K854341 · Johnson & Johnson Professionals, Inc. · Nov 1985
WALKING HEEL
K823394 · Orthopedic Systems, Inc. · Dec 1982
SHOW'RBAG
K822059 · The Healthcare Group Laboratories, Inc. · Jul 1982
CONPHAR CAST HEELS
K803141 · Conphar, Inc. · Jan 1981