Cleared Traditional

NSTRAND IMPLANTATION KIT (K052024) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all North American Scientific, Inc. devices

Submission Details

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
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.

Device Classification

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 17
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K052024.
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · C.R. Bard, Inc. · May 2014
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · C.R. Bard, Inc. · Apr 2006
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004
3M I-125 SEEDS IN ABSORBABLE CARRIER
K801748 · 3M Company · Dec 1980