Cleared Traditional

K935539 - CAPINTEC CRC 35R

K935539 is an FDA 510(k) clearance for CAPINTEC CRC 35R, manufactured by Capintec Instruments, Inc.. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K935539 · Capintec Instruments, Inc. · Radiology device
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Feb 1994
Decision
94d
Days
Class 2
Risk

K935539 is an FDA 510(k) clearance for the CAPINTEC CRC 35R. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Capintec Instruments, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 94 days - within the typical 510(k) review window.

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 Instruments, Inc. devices

FDA 510(k) Submission Details - K935539

510(k) Number K935539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date February 18, 1994
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - KPT Calibrator, Dose, Radionuclide

All 13
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K935539.
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