510(k) · Cleared
ClearedMonteris Medical NeuroBlate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monteris Medical, · ONO Neurosurgical Laser With Mr Thermography
Cleared on Jun 4, 2024 as substantially equivalent to K231061 (Monteris Medical,, 2023) after a 67-day review. Its family tree reaches back 19 generations to 1999. 2 of the 47 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jun 4, 2024
- Review
- 67 days
- Class
- Class II
- Product code
- ONO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K983831 (1999). 41 ancestors in all, the oldest K913475 (1991). 5 later devices descend from it, 4 citing it directly. 2 of the 47 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 15 generations between
- 3 generations backK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
- 2 generations backK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
- 1 generation backK231061 NeuroBlate SystemMonteris Medical, · 2023
- This deviceK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
- Descendant · cites it directly · 1 of its ownK260976 NeuroBlate SystemMonteris Medical · 2026
- Descendant · cites it directly · 1 of its ownK250307 Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation · 2025
- Descendant · cites it directly · 0 of its ownK262315 NeuroBlate SystemMonteris Medical · 2026
- Descendant · 2 generations on · 0 of its ownK253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled…Medtronic Navigation, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1)…Clinical Laserthermia Systems, AB · 2025
Show all 19 generations
- Root · 19 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 18 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 17 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 16 generations backK062086 NavivisionBrainlab AG · 2006
- 15 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- 14 generations backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 13 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 12 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- 11 generations backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- 10 generations backK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
- 9 generations backK170724 NeuroBlate SystemMonteris Medical, · 2017
- 8 generations backK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
- 7 generations backK172881 NeuroBlate SystemMonteris Medical, · 2017
- 6 generations backK173305 NeuroBlate SystemMonteris Medical, · 2017
- 5 generations backK182036 NeuroBlate SystemMonteris Medical, · 2018
- 4 generations backK193375 NeuroBlate SystemMonteris Medical, · 2020
- 3 generations backK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
- 2 generations backK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
- 1 generation backK231061 NeuroBlate SystemMonteris Medical, · 2023
- This deviceK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K260976NeuroBlate SystemMonteris Medical · 2026 · cites it directly1descendant
- K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation · 2025 · cites it directly1descendant
- K262315NeuroBlate SystemMonteris Medical · 2026 · cites it directly0descendants
- K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc. · 2026 · 2 generations on0descendants
- K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −18 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −17 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −16 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −15 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| −14 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −13 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −12 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| −11 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| −10 | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
| −9 | K170724 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −8 | K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017 | Class I |
| −7 | K172881 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −6 | K173305 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −5 | K182036 | NeuroBlate System | Monteris Medical, | 2018 | — |
| −4 | K193375 | NeuroBlate System | Monteris Medical, | 2020 | — |
| −3 | K201056 | NeuroBlate System | Monteris Medical, Inc. | 2020 | — |
| −2 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022 | 1 |
| −1 | K231061 | NeuroBlate System | Monteris Medical, | 2023 | — |
| 0 (this device) | K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024 | — |
| +1 | K260976 | NeuroBlate System | Monteris Medical | 2026 | — |
| +1 | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | 2025 | — |
| +1 | K262315 | NeuroBlate System | Monteris Medical | 2026 | — |
| +2 | K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser… | Medtronic Navigation, Inc. | 2026 | — |
| +1 | K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser… | Clinical Laserthermia Systems, AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have a Class I recall. 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 K260976 NeuroBlate Systemscore 19.9 · 20 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 |
|---|---|---|---|
| * | K231061 | NeuroBlate SystemSummary page 5…nt for use in general and plastic surgery and in dermatology; Stereotaxic instrument Premarket K231061 Notification # Regulation 21 CFR 878.4810 21 CFR 882.4560 Class/ Product Code Clas… | 2023 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 41 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K260976 (Monteris Medical, 2026) has gone furthest, with 1 descendant of its own.
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. 2024, 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 Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.…
Read the full statement (160 words)
The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate
intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified
by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal
therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI
visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible
(conditional) NeuroBlate Laser Delivery Probes. It also provides near real-time thermographic analysis of selected MRI
images.
When interpreted by a trained physician, this System 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 the NeuroBlate
System analysis. The intended patients are adults and pediatric from the age of 2 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240877: Monteris Medical NeuroBlate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240877
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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