Cleared Traditional

K042746 - PET-DOSE

K042746 is an FDA 510(k) clearance for PET-DOSE, manufactured by Comecer S.R.L.. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K042746 · Comecer S.R.L. · Radiology device
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Nov 2004
Decision
49d
Days
Class 2
Risk

K042746 is an FDA 510(k) clearance for the PET-DOSE. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Comecer S.R.L. (Crofton, US). The FDA issued a Cleared decision on November 22, 2004 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1360 - 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.

FDA 510(k) Submission Details - K042746

510(k) Number K042746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date November 22, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPT Device Classification - Class 2, Special Controls

Product Code KPT Calibrator, Dose, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1360
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

Entela, Inc.
NEIL E DEVINE

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.

Regulatory Peers - KPT Calibrator, Dose, Radionuclide

All 31
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K042746.
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K071396 · Capintec, Inc. · Jun 2007
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K030066 · Nuclear Associates · Aug 2003
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K011493 · Mentor Corp. · Oct 2002
CRC-15BT
K020150 · Capintec, Inc. · Aug 2002
K042746 · PET-DOSE
Download PDF Comecer S.R.L.