Cleared Traditional

K932507 - QUICK-CAST IMMOBILIZER (FDA 510(k) Clearance)

Class I Orthopedic device.

K932507 · Landec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
274d
Days
Class 1
Risk

K932507 is an FDA 510(k) clearance for the QUICK-CAST IMMOBILIZER. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Landec Corp. (Menlo Park, US). The FDA issued a Cleared decision on February 23, 1994 after a review of 274 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Landec Corp. devices

Submission Details

510(k) Number K932507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date February 23, 1994
Days to Decision 274 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 122d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.