510(k) · Cleared
ClearedMonteris Medical Ufo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monteris Medical, · HAW Neurological Stereotaxic Instrument
Cleared on Aug 6, 2009 as substantially equivalent to K992304 (Image-Guided Neurologics, Inc., 1999) and 1 other predicate after a 185-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Aug 6, 2009
- Review
- 185 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992304 (1999). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992304 Navigus Trajectory Guide, Model TG-XXXXImage-Guided Neurologics, Inc. · 1999
- This deviceK090240 Monteris Medical UfoMonteris Medical, · 2009
- Descendant · cites it directly · 2 of its ownK180854 Voyager Trajectory Array Guide (V-TAG)Voyager Therapeutics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK250893 Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK191400 Voyager Trajectory Array Guide (V-TAG)Mri Interventions, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K180854Voyager Trajectory Array Guide (V-TAG)Voyager Therapeutics, Inc. · 2018 · cites it directly2descendants
- K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025 · 2 generations on0descendants
- K191400Voyager Trajectory Array Guide (V-TAG)Mri Interventions, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992304 | Navigus Trajectory Guide, Model TG-XXXX | Image-Guided Neurologics, Inc. | 1999 | — |
| 0 (this device) | K090240 | Monteris Medical Ufo | Monteris Medical, | 2009 | — |
| +1 | K180854 | Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. | 2018 | — |
| +2 | K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025 | — |
| +2 | K191400 | Voyager Trajectory Array Guide (V-TAG) | Mri Interventions, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 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.
Planning a device in HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K992304 | Navigus Trajectory Guide, Model TG-XXXXSummary page 2…edicate Device The Monteris Medical UFOTM is substantially equivalent in intended use, technology, design, materials, and physician use to the Navigus Trajectory Guides (K992304 & KO012366). The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of… | 1999 |
| * | K012366 | Navigus II Trajectory GuideSummary page 1…avigus II Trajectory Guide Predicate Device Manufacturers: Image Guided Neurologics K# 012366 Predicate Device Common Name: Frameless Stereotaxic Instrument Guide t Predicate Devic… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180854 | Voyager Trajectory Array Guide (V-TAG) | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Monteris Medical UFOTM is intended to provide stereotactic guidance,
placement and fixation for the operation of instruments or devices during the
planning and operation of neurological procedures performed in conjunction with
preoperative and(or) perioperative MR or CT imaging. These procedures include
laser coagulation, biopsies, catheter placement and electrode procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090240: Monteris Medical Ufo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090240
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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