510(k) · Cleared
ClearedEZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibt SA · KXK Source, Brachytherapy, Radionuclide
Cleared on Jul 16, 2004 as substantially equivalent to K973328 (International Brachytherapy S.A., 1998) and 2 other predicates after a 24-day review. Its family tree reaches back 2 generations to 1987. 8 later devices descend from it.
- Decided
- Jul 16, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K874787 (1987). 5 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 1 generation backK973328 IntersourceInternational Brachytherapy S.A. · 1998
- This deviceK041702 EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 2004
- Descendant · cites it directly · 7 of its ownK062384 Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK092136 Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK180515 GammaTileIsoray Medical, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK190296 GammaTileGt Medical Technologies · 2019
- Descendant · 5 generations on · 1 of its ownK190839 GammaTileGt Medical Technologies · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006 · cites it directly7descendants
- K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009 · 2 generations on4descendants
- K180515GammaTileIsoray Medical, Inc. · 2018 · 3 generations on3descendants
- K190296GammaTileGt Medical Technologies · 2019 · 4 generations on2descendants
- K190839GammaTileGt Medical Technologies · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −1 | K973328 | Intersource | International Brachytherapy S.A. | 1998 | — |
| 0 (this device) | K041702 | EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.) | Ibt SA | 2004 | — |
| +1 | K062384 | Cesium-131 Strand, Strand Preload, Preload, S-Cartridge | Isoray, Inc. | 2006 | — |
| +2 | K092136 | Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 | Isoray Medical, Inc. | 2009 | — |
| +3 | K180515 | GammaTile | Isoray Medical, Inc. | 2018 | — |
| +4 | K190296 | GammaTile | Gt Medical Technologies | 2019 | — |
| +5 | K190839 | GammaTile | Gt Medical Technologies | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
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 KXK? 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 KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K973328 | IntersourceSummary page 1…py Source Class 11device Class of Device: 21 CFR 892.5730, Class 11 Product Code: 90-KXK Intended Use EZ-Pak T M is a packaging change to lnterSourcel10 3 (#K973328), InterSource12 (#K9984235) and InterStrand® (#KO1 1155). There is no change in the intended use of these cleared sourc… | 1998 |
| * | K984235 | Intersource 125, Model 1251LSummary page 1…s of Device: 21 CFR 892.5730, Class 11 Product Code: 90-KXK Intended Use EZ-Pak T M is a packaging change to lnterSourcel10 3 (#K973328), InterSource12 (#K9984235) and InterStrand® (#KO1 1155). There is no change in the intended use of these cleared sources. Please see the referenced Pr… | 1999 |
| * | K011155 | Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062384 | Cesium-131 Strand, Strand Preload, Preload, S-Cartridge | 2006 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062384 (Isoray, Inc., 2006) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K973328.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, 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 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor.
The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041702: EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041702
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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