510(k) · Cleared
ClearedImplant Sciences Corp. Model HDR 4454
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 23, 2007 as substantially equivalent to K042864 (Implant Sciences Corp., 2005) after a 35-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Mar 23, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 1 generation backK042864 Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005
- This deviceK070468 Implant Sciences Corp. Model HDR 4454Implant Sciences Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −1 | K042864 | Implant Sciences Corp, Model HDR-4140 | Implant Sciences Corp. | 2005 | — |
| 0 (this device) | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K042864 | Implant Sciences Corp, Model HDR-4140Summary page 1…arketed Predicate Devices: Implant Sciences Corp. Model HDR-4140, cleared under 510(k) number K042864 dated 06 January 2005 (4) Description of Implant Sciences Corp. Model HDR-4454 169Ytterbium Brachytherapy Source:… | 2005 |
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 21 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042864.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 4454 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 4454 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/K070468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070468: Implant Sciences Corp. Model HDR 4454.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070468
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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