Cleared Traditional

K151946 - Thermofit

K151946 is an FDA 510(k) clearance for Thermofit, manufactured by Orfit Industries. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K151946 · Orfit Industries · Radiology device
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Nov 2015
Decision
118d
Days
Class 2
Risk

K151946 is an FDA 510(k) clearance for the Thermofit. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Orfit Industries (Wijnegem, Belgium, BE). The FDA issued a Cleared decision on November 9, 2015 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151946

510(k) Number K151946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2015
Decision Date November 09, 2015
Days to Decision 118 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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.

Regulatory Consultant

P/L Biomedical
LEE LEICHTER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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