Cleared Traditional

K062825 - AOS MARKER SEEDS

K062825 is an FDA 510(k) clearance for AOS MARKER SEEDS, manufactured by Alpha-Omega Services, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K062825 · Alpha-Omega Services, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
244d
Days
Class 2
Risk

K062825 is an FDA 510(k) clearance for the AOS MARKER SEEDS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Alpha-Omega Services, Inc. (Bellflower, US). The FDA issued a Cleared decision on May 22, 2007 after a review of 244 days - an extended review 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: 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 Alpha-Omega Services, Inc. devices

FDA 510(k) Submission Details - K062825

510(k) Number K062825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2006
Decision Date May 22, 2007
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 107d · This submission: 244d
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 33
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K062825.
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449 · Riverpoint Medical · Feb 2011
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550 · Cp Medical · Jul 2007
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