Cleared Traditional

K932184 - STERILE LEMAITRE GLOW 'N TELL TAPE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932184 · Vascutech, Inc. · Radiology device
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Jul 1993
Decision
78d
Days
Class 2
Risk

K932184 is an FDA 510(k) clearance for the STERILE LEMAITRE GLOW 'N TELL TAPE. Classified as Assembly, Thigh/knee/shank/ankle/foot, External (product code KFX), Class II - Special Controls.

Submitted by Vascutech, Inc. (North Andover, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 890.3500 - the FDA radiology and imaging software oversight 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 Vascutech, Inc. devices

Submission Details

510(k) Number K932184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1993
Decision Date July 22, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFX Assembly, Thigh/knee/shank/ankle/foot, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.