510(k) Report

FDA applicant

Monteris Medical,

Plymouth, MN22 decisions2009–20264 recalls

FDA records 22 decisions for Monteris Medical, (Plymouth, MN) from 2009 to 2026: 22 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONO (Neurosurgical Laser With Mr Thermography). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 61 predicates, 51 of them its own earlier devices. 4 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Monteris Medical, Inc.”, “Monteris Medical”, “Monteris Medical Corp.”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Monteris Medical,’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 22011: 12013: 32014: 22015: 12016: 12017: 42018: 12020: 22023: 22024: 12026 (partial year): 2
2009high 4 (2017) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2017

2014: 22016: 1, 1 Class I2017: 1, 1 Class I
2009high 2 (2014) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Monteris Medical, by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Monteris Medical,’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument16decisions
  • ONONeurosurgical Laser With Mr Thermography3decisions
  • MOSCoil, Magnetic Resonance, Specialty2decisions
  • HAWNeurological Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 44 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 8 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 61 predicates; 51 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 51 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120561Neuroblate SystemMonteris Medical, Inc. · 20137cite it
  • K141983Neuroblate SystemMonteris Medical Corp. · 20145cite it
  • K162762NeuroBlate SystemMonteris Medical, Inc. · 20164cite it
  • K240877Monteris Medical NeuroBlate SystemMonteris Medical, · 20244cite it
  • K143457NeuroBlate SystemMonteris Medical, Inc. · 20154cite it
  • K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 20093cite it

What has FDA decided for it lately?

  • K262315NeuroBlate SystemMonteris Medical · 2026
  • K260976NeuroBlate SystemMonteris Medical · 2026
  • K240877Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
  • K231061NeuroBlate SystemMonteris Medical, · 2023
  • K222983NeuroBlate Fusion-S Software V3.17Monteris Medical, · 2023
  • K201056NeuroBlate SystemMonteris Medical, Inc. · 2020
  • K193375NeuroBlate SystemMonteris Medical, · 2020
  • K182036NeuroBlate SystemMonteris Medical, · 2018

All 11 as Monteris Medical, →All 8 as Monteris Medical, Inc. →All 2 as Monteris Medical →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K171255MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.Oct 5, 2017Class I
  • K143457NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s…Mar 25, 2016Class I
  • K131278FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01…Oct 3, 2014Class II
  • K120561SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01…Oct 3, 2014Class II