Cleared Traditional

K932507 - QUICK-CAST IMMOBILIZER

K932507 is an FDA 510(k) clearance for QUICK-CAST IMMOBILIZER, manufactured by Landec Corp.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 274-day FDA review.

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

FDA 510(k) Submission Details - K932507

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.

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 K932507.
CLINITEX STOCKINETTE
K973417 · Clinitex Medical Corp. · Dec 1997
CLINITEX CAST PADDING
K973420 · Clinitex Medical Corp. · Dec 1997
PROTEC COTTON PADDING BANDAGE
K955320 · Derivadas Degasa S.A. DE C.V. · Jan 1996
CARAPACE STERILE CAST PADDING
K931672 · Carapace, Inc. · Dec 1993
ARTIFLEX(TM)
K910274 · Beiersdorf, Inc. · Mar 1991
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K896634 · Buckman Co., Inc. · Jun 1990