510(k) · Cleared
ClearedLeksell Gamma Knife Perfexion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instrument AB · IWB System, Radiation Therapy, Radionuclide
Cleared on May 9, 2014 as substantially equivalent to K120811 (Elekta Instrument AB, 2012) after a 170-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.
- Decided
- May 9, 2014
- Review
- 170 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924849 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 4 generations backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- 3 generations backK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- 2 generations backK063512 Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · Recalled
- 1 generation backK120811 Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · Recalled
- This deviceK133565 Leksell Gamma Knife PerfexionElekta Instrument AB · 2014
- Descendant · cites it directly · 4 of its ownK151159 Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- Descendant · 3 generations on · 1 of its ownK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151159Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · cites it directly4descendants
- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · cites it directly4descendants
- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 2 generations on3descendants
- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 2 generations on2descendants
- K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −4 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| −3 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| −2 | K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2007 | 4 |
| −1 | K120811 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2012 | 1 |
| 0 (this device) | K133565 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2014 | — |
| +1 | K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015 | 1 |
| +1 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| +2 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
| +2 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
| +3 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -… | Elekta Solutions AB | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 IWB? 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 IWB device
- #1 K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell…score 11.2 · 13 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 |
|---|---|---|---|
| * | K120811 | Leksell Gamma Knife PerfexionSummary page 1…arketed devices to which equivalence is being claimed }510(k) # Leksell Gamma Knife® Perfexion TM JK120811 5. Other relevant submissions Devices51… | 2012 |
What descends from it? (6)
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 19 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K151159 (Elekta Instrument AB, 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IWB
57in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IWB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWB
3in 2025
MAUDE reports naming product code IWB, 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 | 1 | — | 3 | 8 |
| 2008 | 0 | — | 3 | 15 |
| 2009 | 1 | — | 1 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 3 | 170 | 1 | 8 |
| 2015 | 3 | 79 | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 57 | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Leksell Gamma Knife® Perfexion™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary adenomas and recurrent glioblastomas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133565: Leksell Gamma Knife Perfexion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133565
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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