510(k) · Cleared
ClearedI-Plant, Model 3500
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 Mar 21, 2000 as substantially equivalent to K990193 (Implant Sciences Corp., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 21, 2000
- Review
- 90 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). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK994317 I-Plant, Model 3500Implant Sciences Corp. · 2000
- Descendant · cites it directly · 1 of its ownK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
- Descendant · cites it directly · 0 of its ownK141038 Ant Model 1Advanced Nuclide Technologies, LLC · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K994317 | I-Plant, Model 3500 | Implant Sciences Corp. | 2000 | — |
| +1 | K090366 | Spec Model M-31 | Source Production & Equipment Co., Inc. | 2009 | — |
| +1 | K141038 | Ant Model 1 | Advanced Nuclide Technologies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 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…fication: Brachytherapy Radionuclide Source, 21 CFR 892.5730 - Class |l Predicate Devices Implant Sciences, Inc. |-Plant™ |-125 Brachytherapy Seeds (Model 3000) [510(k) K990193] Medi-Physics, Inc. (Amersham) 1-125 Seeds (No. 6711) [510(k) K914281] Description The Implant Sciences '*° lodine (Mode! 3500… | 1999 |
| * | K914281 | I-125 Seeds, Code: 6711Summary page 1…Predicate Devices Implant Sciences, Inc. |-Plant™ |-125 Brachytherapy Seeds (Model 3000) [510(k) K990193] Medi-Physics, Inc. (Amersham) 1-125 Seeds (No. 6711) [510(k) K914281] Description The Implant Sciences '*° lodine (Mode! 3500) Brachytherapy Seeds consist of a laser welded titanium capsule contai… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K090366 (Source Production & Equipment Co., Inc., 2009) has gone furthest, with 1 descendant of its own.
- 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?
The Implant Sciences ' lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The ' |odine 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 and other accessible tumors are commonly treated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994317: I-Plant, Model 3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994317
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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