Cleared Special

K091598 - LUMENCATH APPLICATOR SET

K091598 is the FDA 510(k) clearance for LUMENCATH APPLICATOR SET by Nucletron Corp.. It is a Class 2 Radiology device (product code JAQ) cleared through the Special 510(k) pathway after a 26-day FDA review.

K091598 · Nucletron Corp. · Radiology device
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Jun 2009
Decision
26d
Days
Class 2
Risk

K091598 is an FDA 510(k) clearance for the LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCA.... 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 June 29, 2009 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nucletron Corp. devices

Submission Details

510(k) Number K091598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date June 29, 2009
Days to Decision 26 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K091598.
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K092405 · Hologic, Inc. · Aug 2009
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CENTERING INTRALUMINAL APPLICATOR
K082653 · Varian Medical Systems, Inc. · Oct 2008
CONTURA LUMEN MARKER
K082264 · Senorx, Inc. · Sep 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179 · Hologic, Inc. · May 2008