510(k) · Cleared
ClearedNeuroBlate Fusion-S Software V3.17
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monteris Medical, · GEX Powered Laser Surgical Instrument
Cleared on Mar 15, 2023 as substantially equivalent to K193375 (Monteris Medical,, 2020) and 1 other predicate after a 168-day review. Its family tree reaches back 17 generations to 1999. 2 of the 43 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Mar 15, 2023
- Review
- 168 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K983831 (1999). 35 ancestors in all, the oldest K913475 (1991). 7 later devices descend from it, 1 citing it directly. 2 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 13 generations between
- 3 generations backK182036 NeuroBlate SystemMonteris Medical, · 2018
- 2 generations backK193375 NeuroBlate SystemMonteris Medical, · 2020
- 1 generation backK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
- This deviceK222983 NeuroBlate Fusion-S Software V3.17Monteris Medical, · 2023
- 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
Show all 17 generations
- Root · 17 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 16 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 15 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 14 generations backK062086 NavivisionBrainlab AG · 2006
- 13 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- 12 generations backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 11 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 10 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- 9 generations backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- 8 generations backK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
- 7 generations backK170724 NeuroBlate SystemMonteris Medical, · 2017
- 6 generations backK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
- 5 generations backK172881 NeuroBlate SystemMonteris Medical, · 2017
- 4 generations backK173305 NeuroBlate SystemMonteris Medical, · 2017
- 3 generations backK182036 NeuroBlate SystemMonteris Medical, · 2018
- 2 generations backK193375 NeuroBlate SystemMonteris Medical, · 2020
- 1 generation backK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
- This deviceK222983 NeuroBlate Fusion-S Software V3.17Monteris Medical, · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
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 |
|---|---|---|---|---|---|
| −17 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −16 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −15 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −14 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −13 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| −12 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −11 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −10 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| −9 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| −8 | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
| −7 | K170724 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −6 | K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017 | Class I |
| −5 | K172881 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −4 | K173305 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −3 | K182036 | NeuroBlate System | Monteris Medical, | 2018 | — |
| −2 | K193375 | NeuroBlate System | Monteris Medical, | 2020 | — |
| −1 | K201056 | NeuroBlate System | Monteris Medical, Inc. | 2020 | — |
| 0 (this device) | K222983 | NeuroBlate Fusion-S Software V3.17 | Monteris Medical, | 2023 | — |
| +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 | 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 |
| 2013 | 1 | 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.
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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193375 | NeuroBlate SystemSummary page 4…evice Manufacturer: Monteris Medical Predicate Device Common Name: Monteris NeuroBlate System Predicate Device Premarket Notification # K193375, K201056 Predicate Device Regulation: 21 CFR 878.4810 Laser surgic… | 2020 |
| * | K201056 | NeuroBlate SystemSummary page 4…ufacturer: Monteris Medical Predicate Device Common Name: Monteris NeuroBlate System Predicate Device Premarket Notification # K193375, K201056 Predicate Device Regulation: 21 CFR 878.4810 Laser surgical instru… | 2020 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231061 | NeuroBlate System | 2023 | 6 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 35 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K231061 (Monteris Medical,, 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K193375.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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 (145 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222983: NeuroBlate Fusion-S Software V3.17.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222983
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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