510(k) · Cleared
ClearedElekta Stereotactic Guide
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 Jul 20, 1999 as substantially equivalent to K955397 (Nomos Corp., 1996) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jul 20, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K851659 (1985). 8 ancestors in all, the oldest K830999 (1983). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851659 | Skull Mounted Stereotactic Surgical Device | Medco Products, Co., Inc. | 1985 | — |
| −1 | K955397 | Mayfield-Acciss Workstation | Nomos Corp. | 1996 | — |
| 0 (this device) | K991636 | Elekta Stereotactic Guide | Elekta Instrument AB | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 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 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? (3)
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 |
|---|---|---|---|
| * | K955397 | Mayfield-Acciss WorkstationSummary page 1…ion Name: Stereotaxic Instrument 21 CFR 882.4560 16.3 IDENTIFICATION OF PREDICATE DEVICES Company Device S10(k) No. Date Cleared Ohio Medical Mayfield-ACCISS Workstation K955397 04/30/96 Ad-Tech DAP II Biopsy Guide K830999 07/12/83 Elekta, AB Leksell Stereotactic System K972324 03/02/98 120 === Page 2 =… | 1996 |
| * | K830999 | Dap II Biopsy GuideSummary page 1…560 16.3 IDENTIFICATION OF PREDICATE DEVICES Company Device S10(k) No. Date Cleared Ohio Medical Mayfield-ACCISS Workstation K955397 04/30/96 Ad-Tech DAP II Biopsy Guide K830999 07/12/83 Elekta, AB Leksell Stereotactic System K972324 03/02/98 120 1< q41€%6 Elekta Stereotactic Guide Origi… | 1983 |
| * | K972324 | Leksell Stereotactic SystemSummary page 1…ce S10(k) No. Date Cleared Ohio Medical Mayfield-ACCISS Workstation K955397 04/30/96 Ad-Tech DAP II Biopsy Guide K830999 07/12/83 Elekta, AB Leksell Stereotactic System K972324 03/02/98 120 1< q41€%6 Elekta Stereotactic Guide Original Premarket 510(k) Notification 16.4 16.5 DEVICE DES… | 1998 |
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 14 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 4 other devices also cite its predicate K955397.
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 Elekta Stereotactic Guide is indicated for use in guidance and stereotactic instrument positioning in open cranial procedures and surgeries normally performed with traditional stereotactic apparatus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991636: Elekta Stereotactic Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991636
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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