Cleared Traditional

K990990 - CET PROSTATE APPLICATOR SET

K990990 is an FDA 510(k) clearance for CET PROSTATE APPLICATOR SET, manufactured by Nucletron Corp.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K990990 · Nucletron Corp. · Radiology device
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Oct 1999
Decision
197d
Days
Class 2
Risk

K990990 is an FDA 510(k) clearance for the CET PROSTATE APPLICATOR SET, PART NUMBER 089.066. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on October 7, 1999 after a review of 197 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Nucletron Corp. devices

FDA 510(k) Submission Details - K990990

510(k) Number K990990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1999
Decision Date October 07, 1999
Days to Decision 197 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 121
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K990990.
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K993472 · Mick Radio-Nuclear Instruments, Inc. · Jan 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
K993400 · Mick Radio-Nuclear Instruments, Inc. · Jan 2000
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · Cook, Inc. · May 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338 · Nucletron Corp. · Apr 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE
K983341 · Nucletron Corp. · Apr 1999