Cleared Traditional

K013689 - RE-ENTRANT CHAMBER

K013689 is an FDA 510(k) clearance for RE-ENTRANT CHAMBER, 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 238-day FDA review.

K013689 · Sun Nuclear Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
238d
Days
Class 2
Risk

K013689 is an FDA 510(k) clearance for the RE-ENTRANT CHAMBER. 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 July 2, 2002 after a review of 238 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 Sun Nuclear Corp. devices

FDA 510(k) Submission Details - K013689

510(k) Number K013689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date July 02, 2002
Days to Decision 238 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
131d slower than avg
Panel avg: 107d · This submission: 238d
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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