Cleared Traditional

K880272 - CAL/RAD UPGRADE MODEL 1030

K880272 is an FDA 510(k) clearance for CAL/RAD UPGRADE MODEL 1030, manufactured by Sun Nuclear Corp.. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K880272 · Sun Nuclear Corp. · Radiology device
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Feb 1988
Decision
39d
Days
Class 2
Risk

K880272 is an FDA 510(k) clearance for the CAL/RAD UPGRADE MODEL 1030. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Sun Nuclear Corp. (Melbourne, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 39 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.

View all Sun Nuclear Corp. devices

FDA 510(k) Submission Details - K880272

510(k) Number K880272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1988
Decision Date February 29, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
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.

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