Cleared Abbreviated

K103449 - BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS

K103449 is an FDA 510(k) clearance for BRACHYTHERAPY NEEDLES, manufactured by Riverpoint Medical. The device is a Class 2 Radiology device with product code KXK cleared through the Abbreviated 510(k) pathway after a 94-day FDA review.

K103449 · Riverpoint Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
94d
Days
Class 2
Risk

K103449 is an FDA 510(k) clearance for the BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on February 25, 2011 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Riverpoint Medical devices

FDA 510(k) Submission Details - K103449

510(k) Number K103449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2010
Decision Date February 25, 2011
Days to Decision 94 days
Submission Type Abbreviated
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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Standards-based clearance path.

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 137
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K103449.
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979 · Biocompatibles, Inc. · Oct 2011
GLIASITE RTS
K111931 · Isoray Medical, Inc. · Aug 2011
AOS ORION IR-192 SOURCE CABLE
K102811 · Alpha-Omega Services, Inc. · Jun 2011
I-SEED
K103319 · Theragenics Corp. · Jan 2011
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
K100847 · Biocompatibles, Inc. · May 2010
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009