Xodus Medical, Inc.: FDA clearances and approvals
Xodus Medical, Inc. has 6 FDA 510(k) clearances (first 2006, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time: 44 days. openFDA lists 3 product recalls by a recalling firm named Xodus Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 48 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 29 |
Review time against the same product codes
Since 2017, Xodus Medical, Inc.'s cleared 510(k)s took a median 38 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| DWJ | System, Thermal Regulating | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 | 1 |
Review panels
Most recent Xodus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260903 | Hot Pink Pad Warming System | DWJ | 2026-04-16 | 29 |
| K182080 | Scope Antifogging System | GCJ | 2018-09-19 | 48 |
| K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | GEI | 2008-08-12 | 61 |
| K063587 | XODUS MEDICAL ANTI-FOG SOLUTION | OCT | 2007-01-09 | 39 |
| K053433 | CAUTERY TIP CLEANER, MODEL 30500 | GEI | 2006-01-19 | 41 |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | FTA | 2006-01-19 | 50 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-09-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Xodus Medical, Inc. have?
Xodus Medical, Inc. has 6 FDA 510(k) clearances (first 2006, latest 2026), across 5 product codes in 3 review panels.
How long does FDA take to clear Xodus Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Xodus Medical, Inc.'s cleared 510(k)s is 44 days.
What devices does Xodus Medical, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); DWJ (System, Thermal Regulating, 1); FTA (Light, Surgical, Accessories, 1).
Has Xodus Medical, Inc. had device recalls?
openFDA lists 3 product recalls in 1 recall event by a recalling firm whose name matches Xodus Medical, Inc; the most recent began 2019-09-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Xodus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Xodus Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.