510(k) · Cleared
ClearedLeksell Surgiplan with Imagemerge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instrument AB · HAW Neurological Stereotaxic Instrument
Cleared on Feb 12, 2004 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Feb 12, 2004
- Review
- 118 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK033340 Leksell Surgiplan with ImagemergeElekta Instrument AB · 2004
- Descendant · cites it directly · 5 of its ownK080250 Leksell Surgiplan, Model 1006947Elekta Instrument AB · 2008
- Descendant · 2 generations on · 4 of its ownK092192 Waypoint Stereotactic SystemFHC, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK132611 Microtable SystemFred Haer Company, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK233703 Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK231141 STarFix Designer Software C0265FHC, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080250Leksell Surgiplan, Model 1006947Elekta Instrument AB · 2008 · cites it directly5descendants
- K092192Waypoint Stereotactic SystemFHC, Inc. · 2010 · 2 generations on4descendants
- K132611Microtable SystemFred Haer Company, Inc. · 2014 · 3 generations on1descendant
- K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. · 2024 · 4 generations on0descendants
- K231141STarFix Designer Software C0265FHC, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033340 | Leksell Surgiplan with Imagemerge | Elekta Instrument AB | 2004 | — |
| +1 | K080250 | Leksell Surgiplan, Model 1006947 | Elekta Instrument AB | 2008 | — |
| +2 | K092192 | Waypoint Stereotactic System | FHC, Inc. | 2010 | — |
| +3 | K132611 | Microtable System | Fred Haer Company, Inc. | 2014 | — |
| +4 | K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. | 2024 | — |
| +3 | K231141 | STarFix Designer Software C0265 | FHC, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
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?
- Of its descendants, K080250 (Elekta Instrument AB, 2008) has gone furthest, with 5 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 | — |
What is it indicated for?
The Leksell SurgiPlan® with ImageMerge TM accessory is a computer system intended for use in planning invasive intra-cranial stereotactic surgical procedures
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033340: Leksell Surgiplan with Imagemerge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033340
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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