510(k) Report

510(k) · Cleared

Cleared

NeuroBlate System

K182036510(k) TraditionalCleared Oct 15, 201877-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Monteris Medical, · GEX Powered Laser Surgical Instrument

Cleared on Oct 15, 2018 as substantially equivalent to K173305 (Monteris Medical,, 2017) and 10 other predicates after a 77-day review. Its family tree reaches back 14 generations to 1999. 2 of the 44 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.

Decided
Oct 15, 2018
Review
77 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
11

Its longest line of descent runs back 14 generations to K983831 (1999). 32 ancestors in all, the oldest K913475 (1991). 11 later devices descend from it, 3 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2007: 1 other ancestor2006: 4 other ancestors2003: 1 other ancestor1999: 1 other ancestor2001: 3 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2000: 1 other ancestor1991: 2 other ancestors2020: 2 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 3 descendants cleared2025: 2 descendants clearedK983831 · VECTORVISION2 · Brainlab AG · 1999K014256 · Kolibri Igs Systems · Brainlab AG · 2002K042721 · Kolibri Spine · Brainlab AG · 2005K062086 · Navivision · Brainlab AG · 2006K081509 · Monteris Medical Autolitt Laser Probe · Monteris Medical, · 2009×2: 2 generations cleared close together, K120561 (2013), K131278 (2013) K141983 · Neuroblate System · Monteris Medical Corp. · 2014 · recalledK143457 · NeuroBlate System · Monteris Medical, Inc. · 2015 · Class I recallK162762 · NeuroBlate System · Monteris Medical, Inc. · 2016×4: 4 generations cleared close together, K170724 (2017), K171255 (2017), K172881 (2017), K173305 (2017) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 5 other ancestors4 generations back: 6 other ancestors5 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants K173305 · NeuroBlate System · Monteris Medical, · 2017K172881 · NeuroBlate System · Monteris Medical, · 2017K171255 · Monteris Medical NeuroBlate System · Monteris Medical, Inc. · 2017 · Class I recallK170724 · NeuroBlate System · Monteris Medical, · 2017K162762 · NeuroBlate System · Monteris Medical, Inc. · 2016K143457 · NeuroBlate System · Monteris Medical, Inc. · 2015 · Class I recallK141983 · Neuroblate System · Monteris Medical Corp. · 2014 · recalledK131278 · Monteris Medical Neuroblate System · Monteris Medical, Inc. · 2013 · recalledK120561 · Neuroblate System · Monteris Medical, Inc. · 2013 · recalledK081509 · Monteris Medical Autolitt Laser Probe · Monteris Medical, · 2009K062086 · Navivision · Brainlab AG · 2006K042721 · Kolibri Spine · Brainlab AG · 2005K014256 · Kolibri Igs Systems · Brainlab AG · 2002K983831 · VECTORVISION2 · Brainlab AG · 1999−10−50
  1. Root · 14 generations backK983831 VECTORVISION2Brainlab AG · 1999
  2. 10 generations between
  3. 3 generations backK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
  4. 2 generations backK172881 NeuroBlate SystemMonteris Medical, · 2017
  5. 1 generation backK173305 NeuroBlate SystemMonteris Medical, · 2017
  6. This deviceK182036 NeuroBlate SystemMonteris Medical, · 2018
  7. Descendant · cites it directly · 10 of its ownK193375 NeuroBlate SystemMonteris Medical, · 2020
  8. Descendant · cites it directly · 9 of its ownK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
  9. Descendant · 2 generations on · 7 of its ownK222983 NeuroBlate Fusion-S Software V3.17Monteris Medical, · 2023
  10. Descendant · 2 generations on · 7 of its ownK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
  11. Descendant · cites it directly · 6 of its ownK231061 NeuroBlate SystemMonteris Medical, · 2023
Show all 14 generations
  1. Root · 14 generations backK983831 VECTORVISION2Brainlab AG · 1999
  2. 13 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
  3. 12 generations backK042721 Kolibri SpineBrainlab AG · 2005
  4. 11 generations backK062086 NavivisionBrainlab AG · 2006
  5. 10 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
  6. 9 generations backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
  7. 8 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
  8. 7 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
  9. 6 generations backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
  10. 5 generations backK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
  11. 4 generations backK170724 NeuroBlate SystemMonteris Medical, · 2017
  12. 3 generations backK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
  13. 2 generations backK172881 NeuroBlate SystemMonteris Medical, · 2017
  14. 1 generation backK173305 NeuroBlate SystemMonteris Medical, · 2017
  15. This deviceK182036 NeuroBlate SystemMonteris Medical, · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2020: 22022: 12023: 22024: 12025: 22026: 3
2020high 3 (2026) · low 0 (2021)2026

Class I recalls in this family

  • K171255 Monteris Medical NeuroBlate Systemdirect predicate · 2017
  • K143457 NeuroBlate Systemdirect predicate · 2015

Most influential descendants

Showing 5 of 11 · See all
  • K193375NeuroBlate SystemMonteris Medical, · 2020 · cites it directly10descendants
  • K201056NeuroBlate SystemMonteris Medical, Inc. · 2020 · cites it directly9descendants
  • K222983NeuroBlate Fusion-S Software V3.17Monteris Medical, · 2023 · 2 generations on7descendants
  • K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · 2 generations on7descendants
  • K231061NeuroBlate SystemMonteris Medical, · 2023 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K983831VECTORVISION2Brainlab AG1999—
−13K014256Kolibri Igs SystemsBrainlab AG2002—
−12K042721Kolibri SpineBrainlab AG2005—
−11K062086NavivisionBrainlab AG2006—
−10K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,2009—
−9K120561Neuroblate SystemMonteris Medical, Inc.20131
−8K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.20131
−7K141983Neuroblate SystemMonteris Medical Corp.20142
−6K143457NeuroBlate SystemMonteris Medical, Inc.2015Class I
−5K162762NeuroBlate SystemMonteris Medical, Inc.2016—
−4K170724NeuroBlate SystemMonteris Medical,2017—
−3K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.2017Class I
−2K172881NeuroBlate SystemMonteris Medical,2017—
−1K173305NeuroBlate SystemMonteris Medical,2017—
0 (this device)K182036NeuroBlate SystemMonteris Medical,2018—
+1K193375NeuroBlate SystemMonteris Medical,2020—
+1K201056NeuroBlate SystemMonteris Medical, Inc.2020—
+2K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,2023—
+2K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.20221
+1K231061NeuroBlate SystemMonteris Medical,2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199510
199610
199710
199810
199910
200010
200130
200310
200640
200710
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202210
202320
202410
202520
202630
FIG. 1 — Lineage of K182036, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K173305NeuroBlate System
Summary page 4
…Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21…
Monteris Medical,2017—
*K172881NeuroBlate System
Summary page 5
…d accessories that create an MRI guided intracranial delivery of precision thermal therapy in the practice of neurosurgery. As previously described in K170724, K171255, K172881, and K173305, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic fo…
Monteris Medical,2017—
*K171255Monteris Medical NeuroBlate System
Summary page 4
…Laser surgical instrument for use in general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810…
Monteris Medical, Inc.2017Class I
*K170724NeuroBlate System
Summary page 4
…aser surgical instrument for use in general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810…
Monteris Medical,2017—
*K162762NeuroBlate System
Summary page 4
…ical instrument for use in general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21…
Monteris Medical, Inc.2016—
*K143457NeuroBlate System
Summary page 4
…rument for use in general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21 CFR 882.…
Monteris Medical, Inc.2015Class I
*K141983Neuroblate System
Summary page 4
…r use in general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21 CFR 882.4560 Cla…
Monteris Medical Corp.20142
*K131955Neuroblate (TM) System
Summary page 4
…general and plastic surgery and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21 CFR 882.4560 Class/ Produ…
Monteris Medical, Inc.20132
*K131278Monteris Medical Neuroblate System
Summary page 4
…and in dermatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21 CFR 882.4560 Class/ Product Class II Code…
Monteris Medical, Inc.20131
*K120561Neuroblate System
Summary page 4
…rmatology Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21 CFR 882.4560 Class/ Product Class II Code GEX,…
Monteris Medical, Inc.20131
*K081509Monteris Medical Autolitt Laser Probe
Summary page 4
…Stereotaxic instrument Premarket K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, Notification # K131278, K120561, K081509 Regulation 21 CFR 878.4810 21 CFR 882.4560 Class/ Product Class II Code GEX, HAW…
Monteris Medical,2009—

Also cleared against K173305: 1 other device →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193375NeuroBlate SystemMonteris Medical,202010
K201056NeuroBlate SystemMonteris Medical, Inc.20209
K231061NeuroBlate SystemMonteris Medical,20236

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.

  • K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
  • K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 11 of the 32 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K193375 (Monteris Medical,, 2020) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K173305.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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…

Read the full statement (123 words)

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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.

Also cleared against K173305

1 other device cites the same predicate.

  • K193375NeuroBlate SystemMonteris Medical, · 2020

More from Monteris Medical,

11 FDA decisions under this applicant name. See the company

  • K240877Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
  • K231061NeuroBlate SystemMonteris Medical, · 2023
  • K222983NeuroBlate Fusion-S Software V3.17Monteris Medical, · 2023
  • K193375NeuroBlate SystemMonteris Medical, · 2020
  • K173305NeuroBlate SystemMonteris Medical, · 2017

Recent decisions in GEX

The GEX category page

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  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K182036 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182036: 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/K182036

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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