510(k) · Cleared
ClearedIsis Mer System/Elekta Mer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inomed Medizintechnik GmbH · GZL Electrode, Depth
Cleared on Mar 18, 2005 as substantially equivalent to K970943 (Axon Instruments, Inc., 1997) after a 214-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 18, 2005
- Review
- 214 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970943 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970943 Guideline SystemAxon Instruments, Inc. · 1997
- This deviceK042208 Isis Mer System/Elekta Mer SystemInomed Medizintechnik GmbH · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970943 | Guideline System | Axon Instruments, Inc. | 1997 | — |
| 0 (this device) | K042208 | Isis Mer System/Elekta Mer System | Inomed Medizintechnik GmbH | 2005 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970943 | Guideline SystemSummary page 1…lectrode 84 GZL il 21 CFR 882.1330 4. Predicate Device Identification Legally marketed devices to which equivalence is being claimed 510(k) # Axon Guideline System 3000A K970943 Keypoint / Leadpoint system K944574 5. Other relevant submissions Devices 510(k) # N/A N/A COMPANY CONFIDENTIAL Inomed GmbH Tul… | 1997 |
| Kept off the family tree | K944574 | FDA’s K944574 is Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000, Tilt-in-Space, 6000, Mri) Our OCR of the scanned summary read K944574, FDA’s number for Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000… (Lumex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Keypoint / Leadpoint system”. Kept off the family tree. Summary page 1…. Predicate Device Identification Legally marketed devices to which equivalence is being claimed 510(k) # Axon Guideline System 3000A K970943 Keypoint / Leadpoint system K944574 5. Other relevant submissions Devices 510(k) # N/A N/A COMPANY CONFIDENTIAL Inomed GmbH Tullastr.5a 0-79331 Teningen Tel +49 76… | 1994 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K970943.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ISIS MER System/ Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.
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/K042208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042208: Isis Mer System/Elekta Mer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042208
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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