510(k) · Cleared
ClearedTRANBERG Thermoguide Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Laserthermia Systems, AB · ONO Neurosurgical Laser With Mr Thermography
Cleared on Sep 22, 2022 as substantially equivalent to K181859 (Medtronic Navigation, Inc., 2019) after a 266-day review. Its family tree reaches back 6 generations to 1991. 7 later devices descend from it.
- Decided
- Sep 22, 2022
- Review
- 266 days
- Class
- Class II
- Product code
- ONO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913475 (1991). 13 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 5 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 4 generations backK063505 Visualase Envision Software SystemBiotex, Inc. · 2006
- 3 generations backK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
- 2 generations backK081656 Visualase Thermal Therapy SystemBiotex, Inc. · 2008 · Recalled
- 1 generation backK181859 Visualase Thermal Therapy SystemMedtronic Navigation, Inc. · 2019 · Recalled
- This deviceK214125 TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB · 2022
- Descendant · cites it directly · 6 of its ownK231061 NeuroBlate SystemMonteris Medical, · 2023
- Descendant · 2 generations on · 5 of its ownK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
- Descendant · 3 generations on · 1 of its ownK260976 NeuroBlate SystemMonteris Medical · 2026
- Descendant · 3 generations on · 1 of its ownK250307 Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation · 2025
- Descendant · 3 generations on · 0 of its ownK262315 NeuroBlate SystemMonteris Medical · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231061NeuroBlate SystemMonteris Medical, · 2023 · cites it directly6descendants
- K240877Monteris Medical NeuroBlate SystemMonteris Medical, · 2024 · 2 generations on5descendants
- K260976NeuroBlate SystemMonteris Medical · 2026 · 3 generations on1descendant
- K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation · 2025 · 3 generations on1descendant
- K262315NeuroBlate SystemMonteris Medical · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −5 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −4 | K063505 | Visualase Envision Software System | Biotex, Inc. | 2006 | — |
| −3 | K071328 | Visualase Thermal Therapy System | Biotex, Inc. | 2007 | 1 |
| −2 | K081656 | Visualase Thermal Therapy System | Biotex, Inc. | 2008 | 1 |
| −1 | K181859 | Visualase Thermal Therapy System | Medtronic Navigation, Inc. | 2019 | 1 |
| 0 (this device) | K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | 2022 | — |
| +1 | K231061 | NeuroBlate System | Monteris Medical, | 2023 | — |
| +2 | K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024 | — |
| +3 | K260976 | NeuroBlate System | Monteris Medical | 2026 | — |
| +3 | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | 2025 | — |
| +3 | K262315 | NeuroBlate System | Monteris Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 ONO? 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 ONO device
- #1 K240877 Monteris Medical NeuroBlate Systemscore 24.9 · 19 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 |
|---|---|---|---|
| * | K181859 | Visualase Thermal Therapy SystemSummary page 4…plastic surgery and in dermatology Regulation: 21 CFR 878.4810 Product Code: ONO Predicate Device Medtronic Navigation Inc., Visualase Thermal Therapy System, K181859 Reference Device Monteris Medical Inc., NeuroBlate System, K201056 Device Description The TRANBERG®|Thermoguide Therap… | 2019 |
| † | K201056 | NeuroBlate System | 2020 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K231061 (Monteris Medical,, 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K181859.
How does its category compare?
All ONO devicesONO Neurosurgical Laser With Mr Thermography: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ONO
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · ONO
57in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONO
1in 2017
MAUDE reports naming product code ONO, 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 | 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 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 3 | 57 | 0 | — |
What is it indicated for?
The TRANBERG®|Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton…
Read the full statement (175 words)
The TRANBERG®|Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
The TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of analysis using the TRANBERG®|Thermoguide Therapy System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214125: TRANBERG Thermoguide Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214125
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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