510(k) · Cleared
ClearedLeadpoint Focus Workststion, Leadpoint Focus Notebook System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpine Biomed Aps · GZL Electrode, Depth
Cleared on Dec 12, 2014 as substantially equivalent to K071364 (FHC, Inc., 2007) after a 269-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 12, 2014
- Review
- 269 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970943 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK970943 Guideline SystemAxon Instruments, Inc. · 1997
- 2 generations backK993622 Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd. · 2000
- 1 generation backK071364 Microtargeting Guideline 4000FHC, Inc. · 2007 · Recalled
- This deviceK140680 Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970943 | Guideline System | Axon Instruments, Inc. | 1997 | — |
| −2 | K993622 | Neurotrek Physiological Navigation System for Neurosurgery | Alpha Omega, Ltd. | 2000 | — |
| −1 | K071364 | Microtargeting Guideline 4000 | FHC, Inc. | 2007 | 1 |
| 0 (this device) | K140680 | Leadpoint Focus Workststion, Leadpoint Focus Notebook System | Alpine Biomed Aps | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GZL? 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 GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 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 |
|---|---|---|---|
| * | K071364 | Microtargeting Guideline 4000Summary page 5…ectrode. Product code and Regulation: GZL 21CFR 882.1330 Predicate devices: The Leadpoint Focus is substantially equivalent to the predicate device K071364 Guideline 4000 from FHC, Inc. Company Confidential Alpine Biomed Aps, Tonsbakken 16-18… | 2007 |
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 17 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K071364.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, 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 | 3 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Leadpoint microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes.
The Leadpoint microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140680: Leadpoint Focus Workststion, Leadpoint Focus Notebook System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140680
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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