510(k) · Cleared
ClearedVariSeed 9.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on May 8, 2015 as substantially equivalent to K030534 (Varian Medical Systems, 2003) after a 58-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- May 8, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924240 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924240 Prowess 2000Small Systems Group, Inc. · 1993
- 2 generations backK982821 MMS Therpacplus B3DTUI Model Number 6.7Multimedia Medical Systems, Inc. · 1998
- 1 generation backK030534 Variseed 7.1Varian Medical Systems · 2003 · Recalled
- This deviceK150636 VariSeed 9.0Varian Medical Systems, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK232400 VariSeed (v10)Varian Medical Systems · 2023
Most influential descendants
Showing 1 of 1 · See all- K232400VariSeed (v10)Varian Medical Systems · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924240 | Prowess 2000 | Small Systems Group, Inc. | 1993 | — |
| −2 | K982821 | MMS Therpacplus B3DTUI Model Number 6.7 | Multimedia Medical Systems, Inc. | 1998 | — |
| −1 | K030534 | Variseed 7.1 | Varian Medical Systems | 2003 | 1 |
| 0 (this device) | K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | 2015 | — |
| +1 | K232400 | VariSeed (v10) | Varian Medical Systems | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K030534 | Variseed 7.1Summary page 4…ng,radiation therapy treatment 21CFR892.5050, MUJ, Class II Common/Usual Name: VariSeed, Predicate Devices: VariSeed 7.1 (K030534) Device Description: VariSeed 9.0 is a free-standing PC based treatment planning software pr… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232400 | VariSeed (v10) | 2023 | 0 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K232400 (Varian Medical Systems, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K030534.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
VariSeed is indicated for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document low-dose-rate brachytherapy procedures and for use as a biopsy procedure tracking software application used by medical professionals to plan, guide, and document biopsy procedures based on template guided needle insertion. VariSeed may be used on any patient considered suitable for this type of treatment and is intended to be used outside of the sterile field in an operating room environment or in a normal office environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150636: VariSeed 9.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150636
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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