Cleared Traditional

K843780 - VENT-A-CAST

K843780 is an FDA 510(k) clearance for VENT-A-CAST, manufactured by Orthopedic Technology, Inc.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K843780 · Orthopedic Technology, Inc. · Orthopedic device
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Nov 1984
Decision
49d
Days
Class 1
Risk

K843780 is an FDA 510(k) clearance for the VENT-A-CAST. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Orthopedic Technology, Inc. (Sandy, US). The FDA issued a Cleared decision on November 14, 1984 after a review of 49 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 Orthopedic Technology, Inc. devices

FDA 510(k) Submission Details - K843780

510(k) Number K843780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1984
Decision Date November 14, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
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 18
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K843780.
OEC DESIGN ORTHOPEDIC CAST HEEL
K864092 · Military Engineering, Inc. · Dec 1986
DELTA-LITE CASTING RESIN
K854554 · Johnson & Johnson Professionals, Inc. · Dec 1985
DELTA-LITE CASTING RESIN
K854341 · Johnson & Johnson Professionals, Inc. · Nov 1985
CAST TOE COVER
K823819 · Danek Medical, Inc. · Jan 1983
WALKING HEEL
K823394 · Orthopedic Systems, Inc. · Dec 1982
SHOW'RBAG
K822059 · The Healthcare Group Laboratories, Inc. · Jul 1982