510(k) · Cleared
ClearedTMS-Cobot TS MV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axilum Robotics · QFF Electromechanical Arm For A Transcranial Magnetic Stimulation System
Cleared on Feb 17, 2019 as substantially equivalent to K150641 (Tonica Elektronik A/S, 2015) after a 142-day review. Its family tree reaches back 5 generations to 2008. 1 later device descends from it.
- Decided
- Feb 17, 2019
- Review
- 142 days
- Class
- Class II
- Product code
- QFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070003 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 4 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 3 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 2 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 1 generation backK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
- This deviceK182768 TMS-Cobot TS MVAxilum Robotics · 2019
- Descendant · cites it directly · 0 of its ownK261471 Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261471Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −4 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −3 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −2 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −1 | K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 | — |
| 0 (this device) | K182768 | TMS-Cobot TS MV | Axilum Robotics | 2019 | — |
| +1 | K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 QFF? 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 QFF device
- #1 K261471 Zeta TMS Navigation Systemscore 14.1 · 9 generations · no Class I recall
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 |
|---|---|---|---|
| * | K150641 | MagVita TMS Therapy SystemSummary page 4…Name: 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: QFF Predicate Devices MagVita TMS Therapy System (K150641) Reference Devices Medtech SA ROSA Spine (K151511) Device Description Axilum Robotics TMS-Cobot TS MV is a computer controlled… | 2015 |
| † | K151511 | ROSA Spine | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261471 | Zeta TMS Navigation System | 2026 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K261471 (Zeta Surgical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K150641.
How does its category compare?
All QFF devicesQFF Electromechanical Arm For A Transcranial Magnetic Stimulation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QFF
Too few QFF 510(k)s in any year since 2007 to give a median.
Recalls per year · QFF
No recall names QFF since 2007.
Adverse event reports per year · QFF
No MAUDE report names QFF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182768 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182768: TMS-Cobot TS MV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182768
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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