Cleared Traditional

K090914 - AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E

K090914 is an FDA 510(k) clearance for AXXENT BALLOON APPLICATOR, manufactured by Xoft, Inc.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K090914 · Xoft, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
106d
Days
Class 2
Risk

K090914 is an FDA 510(k) clearance for the AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Xoft, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 16, 2009 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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.

FDA 510(k) Submission Details - K090914

510(k) Number K090914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 01, 2009
Decision Date July 16, 2009
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 48
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K090914.
INTRABEAM NEEDLE APPLICATOR
K110590 · Carl Zeiss Surgical GmbH · Apr 2012
AXXENT RADIATION SHIELD - RIGID
K111299 · Xoft, an Icad Company · Jul 2011
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
K090584 · Carl Zeiss Surgical GmbH · Nov 2009
AXXENT SURFACE APPLICATOR, MODEL 710257
K083734 · Xoft, Inc. · Feb 2009
AXXENT VAGINAL APPLICATOR
K072616 · Xoft, Inc. · May 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K072683 · Xoft, Inc. · Feb 2008
K090914 · AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
Download PDF FDA Summary Xoft, Inc.