510(k) · Cleared
ClearedImplant Sciences Corp, Model HDR-4140
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 Jan 6, 2005 as substantially equivalent to K030745 (Varian Medical Systems, 2003) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it.
- Decided
- Jan 6, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864210 (1986). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- This deviceK042864 Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005
- Descendant · cites it directly · 1 of its ownK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
- Descendant · cites it directly · 0 of its ownK161396 SPEC Model M23Source Production and Equipment Co., Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK141038 Ant Model 1Advanced Nuclide Technologies, LLC · 2014
- Descendant · cites it directly · 0 of its ownK070468 Implant Sciences Corp. Model HDR 4454Implant Sciences Corp. · 2007
Most influential descendants
Showing 4 of 4 · See all- K090366Spec Model M-31Source Production & Equipment Co., Inc. · 2009 · cites it directly1descendant
- K161396SPEC Model M23Source Production and Equipment Co., Inc. · 2016 · cites it directly0descendants
- K141038Ant Model 1Advanced Nuclide Technologies, LLC · 2014 · 2 generations on0descendants
- K070468Implant Sciences Corp. Model HDR 4454Implant Sciences Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K042864 | Implant Sciences Corp, Model HDR-4140 | Implant Sciences Corp. | 2005 | — |
| +1 | K090366 | Spec Model M-31 | Source Production & Equipment Co., Inc. | 2009 | — |
| +1 | K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | 2016 | — |
| +2 | K141038 | Ant Model 1 | Advanced Nuclide Technologies, LLC | 2014 | — |
| +1 | K070468 | Implant Sciences Corp. Model HDR 4454 | Implant Sciences Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K030745 | Gammamed 212 and 232 Source AssemblySummary page 1…ted Predicate Devices: Varian Medical Systems GammaMed 232, cleared under 510(k) number K030745 dated 12 March 2003, and Nucletron Corp. Model 105.002, cleared under 510(k) number… | 2003 |
| * | K953946 | Microselectron-HDR Version 2Summary page 1…ed 12 March 2003, and Nucletron Corp. Model 105.002, cleared under 510(k) number K953946 dated 13 August 1996, and Alpha-Omega Services, Inc. Model CSNOO10-192, cleared und… | 1996 |
| * | K991571 | 10 Curie Irdium 192, CSN00100-192Summary page 1…and Alpha-Omega Services, Inc. Model CSNOO10-192, cleared under 510(k) number K991571 dated 22 February 2000 (4) Description of Implant Sciences Corp. Model HDR-4140 169 Ytterbium Brachytherapy Source:… | 2000 |
What descends from it? (4)
3 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 19 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 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 K030745.
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 Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile…
Read the full statement (103 words)
Implant Sciences Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for
temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected
localized tumors. This source can be used as primary treatment for a variety of anatomical sites
commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum,
esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for
treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently
with or following treatment with other interventions, such as external beam radiation therapy,
hyperthermia or chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042864: Implant Sciences Corp, Model HDR-4140.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042864
Report an extraction error
Are you the manufacturer?
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