Cleared Traditional

K781916 - FLEXT-THERM (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K781916 · E-Z-Em, Inc. · Radiology device
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Feb 1979
Decision
80d
Days
Class 3
Risk

K781916 is an FDA 510(k) clearance for the FLEXT-THERM. Classified as System, Thermographic, Liquid Crystal, Powered (adjunctive Use) (product code KXZ), Class III - Premarket Approval.

Submitted by E-Z-Em, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1979 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2982 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K781916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1978
Decision Date February 02, 1979
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXZ System, Thermographic, Liquid Crystal, Powered (adjunctive Use)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.2982
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.