X-Nav Technologies, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “X-Nav Technologies, LLC” (first 2015, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 230 days. Since 2017 the median was 217 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 251 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 103 |
| 2021 | 0 | — |
| 2022 | 1 | 243 |
| 2023 | 0 | — |
| 2024 | 1 | 217 |
| 2025 | 0 | — |
| 2026 | 1 | 261 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name X-Nav Technologies, LLC took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLV | Dental Stereotaxic Instrument | 3 | 3 |
| QRY | Dental Navigation System | 3 | 3 |
Review panels
- Dental (6)
Most recent X-Nav Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253954 | X-Guide Surgical Navigation System | QRY | 2026-08-28 | 261 |
| K232148 | X-Guide Surgical Navigation System | QRY | 2024-02-21 | 217 |
| K211701 | X-Guide® Surgical Navigation System | QRY | 2022-02-01 | 243 |
| K200662 | X-Guide® Surgical Navigation System | PLV | 2020-05-21 | 69 |
| K192579 | X-Guide Surgical Navigation System | PLV | 2020-02-03 | 137 |
| K150222 | X-Guide Surgical Navigation System | PLV | 2015-10-08 | 251 |
Recalls
4 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2024-03-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named X-Nav Technologies, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06506747: Navigated Photogrammetry Compared to Standard Stereophotogrammetry (Completed, started 2024-07-20)
Frequently asked questions
How many FDA 510(k) clearances are listed under X-Nav Technologies, LLC?
FDA lists 6 510(k) clearances under the applicant name “X-Nav Technologies, LLC” (first 2015, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by X-Nav Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name X-Nav Technologies, LLC is 230 days. Since 2017: 217 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under X-Nav Technologies, LLC?
The most frequent FDA product codes under this applicant name are PLV (Dental Stereotaxic Instrument, 3); QRY (Dental Navigation System, 3).
Next steps
- See all 6 X-Nav Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code PLV, X-Nav Technologies, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.