Cleared Traditional

K020150 - CRC-15BT

K020150 is the FDA 510(k) clearance for CRC-15BT by Capintec, Inc.. It is a Class 2 Radiology device (product code KPT) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K020150 · Capintec, Inc. · Radiology device
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Aug 2002
Decision
198d
Days
Class 2
Risk

K020150 is an FDA 510(k) clearance for the CRC-15BT. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 2, 2002 after a review of 198 days - an extended review 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: 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.

View all Capintec, Inc. devices

Submission Details

510(k) Number K020150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date August 02, 2002
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 107d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - KPT Calibrator, Dose, Radionuclide

Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K020150.
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K813065 · General Electric Co. · Dec 1981
DISPENSER, TECHNETIUM, CLINTICHEM
K770515 · Union Carbide Corp. · Apr 1977