510(k) · Cleared
Recalled · 2005Leksell Surgiplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instruments, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 20, 1995 after a 185-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 20, 1995
- Review
- 185 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK943468 Leksell SurgiplanElekta Instruments, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK961639 Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996
- Descendant · 2 generations on · 1 of its ownK973684 Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998
- Descendant · cites it directly · 0 of its ownK013861 Modification to Leksell Surgiplan with AtlaspaceElekta Instrument AB · 2001
- Descendant · 3 generations on · 0 of its ownK992882 Leksell Image Guidance Surgical System, View Scope…Elekta Instrument AB · 1999
Most influential descendants
Showing 4 of 4 · See all- K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996 · cites it directly2descendants
- K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998 · 2 generations on1descendant
- K013861Modification to Leksell Surgiplan with AtlaspaceElekta Instrument AB · 2001 · cites it directly0descendants
- K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB · 1999 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943468 | Leksell Surgiplan | Elekta Instruments, Inc. | 1995 | — |
| +1 | K961639 | Leksell Image Guidance Surgical System (Ligs) | Elekta Instrument AB | 1996 | — |
| +2 | K973684 | Leksell Viewscope, Leksell Surgiscope, Leksell Freehand | Elekta Instrument AB | 1998 | — |
| +1 | K013861 | Modification to Leksell Surgiplan with Atlaspace | Elekta Instrument AB | 2001 | — |
| +3 | K992882 | Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta Insight | Elekta Instrument AB | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2005 | Not classified | Z-1428-2010 | Other | Images from a different patient can be imported without a warning for the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961639 (Elekta Instrument AB, 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
https://510kreport.com/device/K943468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943468: Leksell Surgiplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943468
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026