510(k) · Cleared
Recalled · Class II · 2014Neuroblate (TM) 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 Jul 30, 2013 as substantially equivalent to K120561 (Monteris Medical, Inc., 2013) after a 33-day review. Its family tree reaches back 6 generations to 1999. 2 of the 43 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 30, 2013
- Review
- 33 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983831 (1999). 23 ancestors in all, the oldest K913475 (1991). 19 later devices descend from it, 3 citing it directly. 2 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 3 generations backK062086 NavivisionBrainlab AG · 2006
- 2 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- 1 generation backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- This deviceK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013
- 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 · 2 generations on · 16 of its ownK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
- Descendant · 2 generations on · 15 of its ownK170724 NeuroBlate SystemMonteris Medical, · 2017
- Descendant · 3 generations on · 14 of its ownK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 19 · See all- K141983Neuroblate SystemMonteris Medical Corp. · 2014 · cites it directly18descendants
- K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 2 generations on17descendants
- K162762NeuroBlate SystemMonteris Medical, Inc. · 2016 · 2 generations on16descendants
- K170724NeuroBlate SystemMonteris Medical, · 2017 · 2 generations on15descendants
- K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −3 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −2 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| −1 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| 0 (this device) | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | — |
| +1 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| +2 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| +2 | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
| +2 | K170724 | NeuroBlate System | Monteris Medical, | 2017 | — |
| +3 | K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017 | Class I |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K120561 | Neuroblate SystemSummary page 1…Monteris Medical Predicate Device Common Name: Monteris NeuroBlateTM System Predicate Device Premarket Notification # K120561 Predicate Device Regulation: 21 CER 878.4810 Laser… | 2013 |
What descends from it? (19)
See all 193 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-0228-2015 | Process control | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. |
| 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.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K141983 (Monteris Medical Corp., 2014) has gone furthest, with 18 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. 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 NeuroBlateTM 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 nmi lasers. The Monteris Medical NeuroBlateTM 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 NeuroBlateTM 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 nmi lasers.
The Monteris Medical NeuroBlateTM 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) NeuroBlateTM 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 NeuroBlateTM System analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131955: Neuroblate (TM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131955
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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