510(k) · Cleared
ClearedVoyager Trajectory Array Guide (V-TAG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voyager Therapeutics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 23, 2018 as substantially equivalent to K090240 (Monteris Medical,, 2009) after a 112-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- Jul 23, 2018
- Review
- 112 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992304 (1999). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992304 Navigus Trajectory Guide, Model TG-XXXXImage-Guided Neurologics, Inc. · 1999
- 1 generation backK090240 Monteris Medical UfoMonteris Medical, · 2009
- This deviceK180854 Voyager Trajectory Array Guide (V-TAG)Voyager Therapeutics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK250893 Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK191400 Voyager Trajectory Array Guide (V-TAG)Mri Interventions, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992304 | Navigus Trajectory Guide, Model TG-XXXX | Image-Guided Neurologics, Inc. | 1999 | — |
| −1 | K090240 | Monteris Medical Ufo | Monteris Medical, | 2009 | — |
| 0 (this device) | K180854 | Voyager Trajectory Array Guide (V-TAG) | Voyager Therapeutics, Inc. | 2018 | — |
| +1 | K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K090240 | Monteris Medical UfoSummary page 4…CITATION: 882.4560 PRODUCT CODE: HAW PREDICATE DEVICE: Monteris UFO (K090240) 3.1 Device Description The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotact… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K250893 (Bayer Medical Care, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180854: Voyager Trajectory Array Guide (V-TAG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180854
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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