510(k) · Cleared
ClearedI-Plant Model 3500 (125IODINE Brachytherapy Seeds)-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Sciences Corp. · KXK Source, Brachytherapy, Radionuclide
Cleared on Dec 4, 2002 as substantially equivalent to K990193 (Implant Sciences Corp., 1999) and 1 other predicate after a 65-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Dec 4, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914281 (1991). 6 ancestors in all, the oldest K852542 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
- 2 generations backK982421 Imagyn 125 I Seed, Model IS 125International Isotopes, Inc. · 1998
- 1 generation backK990193 Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 1999
- This deviceK023242 I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileImplant Sciences Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914281 | I-125 Seeds, Code: 6711 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991 | — |
| −2 | K982421 | Imagyn 125 I Seed, Model IS 125 | International Isotopes, Inc. | 1998 | — |
| −1 | K990193 | Iodine Brachytherapy Seeds, Model 3000 | Implant Sciences Corp. | 1999 | — |
| 0 (this device) | K023242 | I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-Sterile | Implant Sciences Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K990193 | Iodine Brachytherapy Seeds, Model 3000Summary page 1…21 CFR 892.5730 - Class I I Predicate Devices Implant Sciences, Inc. I-Plantm 1-125 Brachytherapy Seeds (Model 3000) [51O(k) K9901931 Medi-Physics, Inc. (Amersham) 1-125 Seeds (No. 671 1) [51O(k) K914281J Description… | 1999 |
| * | K914281 | I-125 Seeds, Code: 6711Summary page 1…therapy Seeds (Model 3000) [51O(k) K9901931 Medi-Physics, Inc. (Amersham) 1-125 Seeds (No. 671 1) [51O(k) K914281J Description The Implant Sciences 125 Iodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule conta… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K990193.
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?
Implant Sciences I-Plant Model 3500 (¹²⁵Iodine Brachytherapy Seed)-Sterile with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of…
Read the full statement (106 words)
Implant Sciences I-Plant Model 3500 (¹²⁵Iodine Brachytherapy Seed)-Sterile with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. I-Plant Model 3500 Brachytherapy Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023242: I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023242
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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