510(k) · Cleared

Recalled · 2011

Axxent Flexishield Mini

K090417510(k) TraditionalCleared Jun 23, 2009125-day reviewClass II21 CFR 892.5710Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Xoft, Inc. · IXI Block, Beam-Shaping, Radiation Therapy

Cleared on Jun 23, 2009 as substantially equivalent to K010172 (Arplay Medical S.A., 2001) after a 125-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.

Decided: Jun 23, 2009
Review: 125 days
Class: Class II
Product code: IXI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010172 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010172 Lead BlocksArplay Medical S.A. · 2001
This deviceK090417 Axxent Flexishield MiniXoft, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010172	Lead Blocks	Arplay Medical S.A.	2001	—
0 (this device)	K090417	Axxent Flexishield Mini	Xoft, Inc.	2009	—

FIG. 1 — Lineage of K090417, 2001–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IXI device

#1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K010172	Lead Blocks Summary page 2 …Summary of the Technological Characteristics- The technological characteristics of the Axxent FlexiShield Mini are the same as the Arplay Medical Lead Blocks approved in K010172. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the…	Arplay Medical S.A.	2001	—

Also cleared against K010172: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 3, 2011	Not classified	Z-1865-2011	Device Design	Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K010172.

How does its category compare?

All IXI devices

IXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · IXI

2in 2022

2007high 3 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXI

90in 2013

2007high 90 (2013) · low 78 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IXI

2in 2013

2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IXI

1in 2016

2007high 28 (2011) · low 0 (2007)2025

MAUDE reports naming product code IXI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	0	—	1	0
2009	3	78	0	0
2010	0	—	0	1
2011	2	—	1	28
2012	1	—	1	3
2013	3	90	2	2
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	1
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	2	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	1	—	0	—

What is it indicated for?

To shape the beam from a low energy radiation therapy source up to 50 kVp.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090417 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090417: Axxent Flexishield Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090417

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026