510(k) · Cleared
Recalled · Class II · 2014Neuroblate 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 Apr 1, 2013 as substantially equivalent to K081509 (Monteris Medical,, 2009) after a 402-day review. Its family tree reaches back 5 generations to 1999. 2 of the 44 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled once.
- Decided
- Apr 1, 2013
- Review
- 402 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K983831 (1999). 22 ancestors in all, the oldest K913475 (1991). 21 later devices descend from it, 7 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 2 generations backK062086 NavivisionBrainlab AG · 2006
- 1 generation backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- This deviceK120561 Neuroblate SystemMonteris Medical, Inc. · 2013
- Descendant · cites it directly · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · cites it directly · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · cites it directly · 18 of its ownK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- Descendant · 2 generations on · 17 of its ownK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- Descendant · cites it directly · 16 of its ownK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · cites it directly19descendants
- K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · cites it directly19descendants
- K141983Neuroblate SystemMonteris Medical Corp. · 2014 · cites it directly18descendants
- K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 2 generations on17descendants
- K162762NeuroBlate SystemMonteris Medical, Inc. · 2016 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −2 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −1 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| 0 (this device) | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | — |
| +1 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
| +1 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +1 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| +2 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| +1 | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081509 | Monteris Medical Autolitt Laser ProbeSummary page 1…anufacturer: Monteris Medical Predicate Device Common Name: Monteris AutoLlT System Predicate Device Premarket Notification # K08 1509 Predicate Device Regulation: 21 CFR 878.4810 Laser surgical… | 2009 |
What descends from it? (21)
See all 217 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2014 | Class II | Z-0227-2015 | Process control | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. |
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 14 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K131955 (Monteris Medical, Inc., 2013) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K081509.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TM 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 nmn lasers. The Monteris Medical NeuroBlate TM 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 (121 words)
The Monteris Medical NeuroBlate TM 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 nmn lasers.
The Monteris Medical NeuroBlate TM 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) Neurolate Laser Delivery Probe. 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 tM System analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120561: 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/K120561
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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