Cleared Traditional

K052024 - NSTRAND IMPLANTATION KIT

K052024 is an FDA 510(k) clearance for NSTRAND IMPLANTATION KIT, manufactured by North American Scientific, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K052024 · North American Scientific, Inc. · Radiology device
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Sep 2005
Decision
43d
Days
Class 2
Risk

K052024 is an FDA 510(k) clearance for the NSTRAND IMPLANTATION KIT. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by North American Scientific, Inc. (Chatsworth, US). The FDA issued a Cleared decision on September 7, 2005 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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.

FDA 510(k) Submission Details - K052024

510(k) Number K052024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date September 07, 2005
Days to Decision 43 days
Submission Type Traditional
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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 145
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K052024.
SURTRAK IMPLANTATION KIT
K060679 · North American Scientific, Inc. · Apr 2006
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · C.R. Bard, Inc. · Apr 2006
CURAY CUSTOM SEED ARRAY
K053595 · Biolucent, Inc. · Feb 2006
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K043596 · Theragenics Corp. · Jan 2005
OPTISTRAND, MODEL 1032S
K043336 · Ibt SA · Jan 2005
K052024 · NSTRAND IMPLANTATION KIT
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