Cleared Traditional

K091117 - ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA

K091117 is an FDA 510(k) clearance for ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHY..., manufactured by Isoaid, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K091117 · Isoaid, LLC · Radiology device
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Sep 2009
Decision
151d
Days
Class 2
Risk

K091117 is an FDA 510(k) clearance for the ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoaid, LLC (Port Richey, US). The FDA issued a Cleared decision on September 15, 2009 after a review of 151 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 Isoaid, LLC devices

FDA 510(k) Submission Details - K091117

510(k) Number K091117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date September 15, 2009
Days to Decision 151 days
Submission Type Traditional
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
44d slower than avg
Panel avg: 107d · This submission: 151d
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 128
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K091117.
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
ACU007S
K092522 · Oncology Systems, Inc. · Nov 2009
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
K092458 · Isoray Medical, Inc. · Aug 2009
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
K092136 · Isoray Medical, Inc. · Aug 2009
SPEC MODEL M-31
K090366 · Source Production & Equipment Co., Inc. · Apr 2009