510(k) · Cleared
ClearedNeuroBlate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monteris Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 26, 2016 as substantially equivalent to K120561 (Monteris Medical, Inc., 2013) and 2 other predicates after a 26-day review. Its family tree reaches back 9 generations to 1999. 2 of the 44 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Oct 26, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K983831 (1999). 27 ancestors in all, the oldest K913475 (1991). 16 later devices descend from it, 4 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations between
- 3 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 2 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- 1 generation backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- This deviceK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
- Descendant · cites it directly · 15 of its ownK170724 NeuroBlate SystemMonteris Medical, · 2017
- Descendant · cites it directly · 14 of its ownK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 13 of its ownK172881 NeuroBlate SystemMonteris Medical, · 2017
- Descendant · 2 generations on · 12 of its ownK173305 NeuroBlate SystemMonteris Medical, · 2017
- Descendant · cites it directly · 11 of its ownK182036 NeuroBlate SystemMonteris Medical, · 2018
Show all 9 generations
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 7 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 6 generations backK062086 NavivisionBrainlab AG · 2006
- 5 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- 4 generations backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 3 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 2 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- 1 generation backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- This deviceK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K170724NeuroBlate SystemMonteris Medical, · 2017 · cites it directly15descendants
- K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · cites it directly14descendants
- K172881NeuroBlate SystemMonteris Medical, · 2017 · cites it directly13descendants
- K173305NeuroBlate SystemMonteris Medical, · 2017 · 2 generations on12descendants
- K182036NeuroBlate SystemMonteris Medical, · 2018 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −8 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −7 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −6 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −5 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| −4 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −3 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −2 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| −1 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| 0 (this device) | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
| +1 | K170724 | NeuroBlate System | Monteris Medical, | 2017 | — |
| +1 | K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017 | Class I |
| +1 | K172881 | NeuroBlate System | Monteris Medical, | 2017 | — |
| +2 | K173305 | NeuroBlate System | Monteris Medical, | 2017 | — |
| +1 | K182036 | NeuroBlate System | Monteris Medical, | 2018 | — |
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 |
|---|---|---|
| 2017 | 4 | 1 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K120561 | Neuroblate SystemSummary page 4…anufacturer: Monteris Medical Predicate Device Common Name: Monteris NeuroBlate™ System Predicate Device Premarket Notification # K120561, K141983, K14347 Predicate Device Regulation: 21 CFR 878.4810… | 2013 |
| * | K141983 | Neuroblate SystemSummary page 4…er: Monteris Medical Predicate Device Common Name: Monteris NeuroBlate™ System Predicate Device Premarket Notification # K120561, K141983, K14347 Predicate Device Regulation: 21 CFR 878.4810 Laser sur… | 2014 |
| * | K143457 | NeuroBlate SystemSummary page 5…MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery. As previously described in K143457, the NeuroBlate System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the bra… | 2015 |
What descends from it? (16)
See all 164 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 17 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170724 (Monteris Medical,, 2017) has gone furthest, with 15 descendants of its own.
- 6 other devices also cite its predicate K120561.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 indicated for use to ablate, necrotize, or coagulate soft tissue 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…
Read the full statement (119 words)
The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue 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 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/K162762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162762: NeuroBlate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162762
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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