510(k) Report

510(k) · Cleared

Cleared

MagVita TMS Therapy w/MagPro R20

K172667510(k) SpecialCleared Oct 5, 201730-day reviewClass II21 CFR 882.5805

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tonica Elektronik A/S · OBP Transcranial Magnetic Stimulator

Cleared on Oct 5, 2017 as substantially equivalent to K170114 (Tonica Elektronik A/S, 2017) after a 30-day review. Its family tree reaches back 6 generations to 2008. 40 later devices descend from it.

Decided
Oct 5, 2017
Review
30 days
Class
Class II
Product code
OBP
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to DEN070003 (2008). 40 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2018: 1 descendant cleared2025: 12 descendants cleared2019: 3 descendants cleared2021: 2 descendants cleared2024: 4 descendants cleared2023: 8 descendants cleared2022: 2 descendants cleared2026: 7 descendants cleared×2: 2 generations cleared close together, DEN070003 (2008), K083538 (2008) K130233 · Neurostar TMS Therapy System · Neuronetics · 2013K133408 · Neurostar TMS Therapy System · Neuronetics · 2014K150641 · MagVita TMS Therapy System · Tonica Elektronik A/S · 2015K170114 · MagVita TMS Therapy - w/MagPro R20 · Tonica Elektronik A/S · 201720052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 10 descendants4 generations forward: 9 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants K170114 · MagVita TMS Therapy - w/MagPro R20 · Tonica Elektronik A/S · 2017K150641 · MagVita TMS Therapy System · Tonica Elektronik A/S · 2015K133408 · Neurostar TMS Therapy System · Neuronetics · 2014K130233 · Neurostar TMS Therapy System · Neuronetics · 2013K083538 · Neurostar TMS Therapy System, Model 1.1 · Neuronetics · 2008 · recalledDEN070003 · Neurostar TMS System · Neuronetics · 2008−50+5
  1. Root · 6 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
  2. 5 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
  3. 4 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
  4. 3 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
  5. 2 generations backK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
  6. 1 generation backK170114 MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S · 2017
  7. This deviceK172667 MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S · 2017
  8. Descendant · cites it directly · 39 of its ownK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
  9. Descendant · cites it directly · 24 of its ownK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
  10. Descendant · 2 generations on · 19 of its ownK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
  11. Descendant · 3 generations on · 13 of its ownK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
  12. Descendant · 2 generations on · 10 of its ownK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2018: 12019: 32020: 12021: 22022: 22023: 82024: 42025: 122026: 7
2018high 12 (2025) · low 1 (2018)2026

Most influential descendants

Showing 5 of 40 · See all
  • K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018 · cites it directly39descendants
  • K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020 · cites it directly24descendants
  • K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022 · 2 generations on19descendants
  • K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023 · 3 generations on13descendants
  • K182853HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6DEN070003Neurostar TMS SystemNeuronetics2008—
−5K083538Neurostar TMS Therapy System, Model 1.1Neuronetics20081
−4K130233Neurostar TMS Therapy SystemNeuronetics2013—
−3K133408Neurostar TMS Therapy SystemNeuronetics2014—
−2K150641MagVita TMS Therapy SystemTonica Elektronik A/S2015—
−1K170114MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S2017—
0 (this device)K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S2017—
+1K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S2018—
+1K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S2020—
+2K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced…Neuronetics, Inc.2022—
+3K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics2023—
+2K182853HORIZON TMS Therapy SystemMagstim Company, Ltd.20192

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201930
202010
202120
202220
202380
202440
2025120
202670
FIG. 1 — Lineage of K172667, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OBP? 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 OBP device

  1. #1 K251119 MagVenture TMS Therapy Systemscore 21.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K170114MagVita TMS Therapy - w/MagPro R20
Summary page 4
…CFR 882.5805, Product Code OBP] Classification: Class II Medical Device Predicate Devices: MagVita TMS Therapy w/MagPro R20, K170114 Special Controls: The 510k submission addressed the special controls required by regulation an…
Tonica Elektronik A/S2017—

Also cleared against K170114: 1 other device →

What descends from it? (40)

See all 40

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S201839
K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S202024
K251125MagVenture TMS Therapy SystemTonica Elektronik A/S20251

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 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K173620 (Tonica Elektronik A/S, 2018) has gone furthest, with 39 descendants of its own.
  • 1 other device also cites its predicate K170114.

How does its category compare?

All OBP devices

OBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · OBP

12in 2025

2008: 22013: 22014: 12015: 22016: 32017: 82018: 42019: 32020: 12021: 52022: 62023: 72024: 52025: 122026 (partial year): 8
2007high 12 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBP

125in 2025

2016: 101 days median2017: 73 days median2018: 144 days median2019: 156 days median2021: 132 days median2022: 168 days median2023: 119 days median2024: 266 days median2025: 125 days median2026 (partial year): 176 days median
2007high 266 (2024) · low 73 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OBP

1in 2018

2009: 12018: 12026 (partial year): 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OBP

81in 2025

2009: 32011: 52012: 32013: 12015: 32016: 62017: 32018: 62019: 122020: 122021: 152022: 592023: 432024: 502025: 81
2007high 81 (2025) · low 0 (2007)2025

MAUDE reports naming product code OBP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—13
20100—00
20110—05
20120—03
20132—01
20141—00
20152—03
2016310106
201787303
2018414416
20193156012
20201—012
20215132015
20226168059
20237119043
20245266050
202512125081
202681761—

What is it indicated for?

The MagVita TMS Therapy – w/MagPro R20 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Indications for use as stated in the FDA summary.

Also cleared against K170114

1 other device cites the same predicate.

  • K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025

More from Tonica Elektronik A/S

18 FDA decisions under this applicant name. See the company

  • K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026
  • K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K252032T65 (9016E061-)Tonica Elektronik A/S · 2025
  • K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/S · 2023

Recent decisions in OBP

The OBP category page

  • K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co. · 2026
  • K260691BTL-699BTL Industries, Inc. · 2026
  • K261228QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026
  • K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH · 2026
  • K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026

https://510kreport.com/device/K172667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172667: MagVita TMS Therapy w/MagPro R20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172667

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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