Tusker Medical, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Tusker Medical, Inc.” (first 2017, latest 2026), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 164 days. 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 |
|---|---|---|
| 2017 | 1 | 62 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 265 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tusker Medical, Inc. took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETD | Tube, Tympanostomy | 2 | 2 |
| QJA | Tympanostomy Tube Delivery Product With Drug | 1 | 0 |
Review panels
Most recent Tusker Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery Device | ETD | 2026-04-23 | 265 |
| K171239 | TULA Tube Delivery System | ETD | 2017-06-28 | 62 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190016 | PMA | Tula® System | 2019-11-25 |
Recalls
openFDA lists no recalls under a recalling firm named Tusker Medical, Inc..
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 Tusker Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03323736: In-Office Tympanostomy Tube Placement in Children (OTTER) (Completed, started 2017-10-31)
- NCT03119181: Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane (Completed, started 2017-04-27)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tusker Medical, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Tusker Medical, Inc.” (first 2017, latest 2026), plus 1 PMA decision, 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 Tusker Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tusker Medical, Inc. is 164 days.
Which FDA product codes appear under Tusker Medical, Inc.?
The most frequent FDA product codes under this applicant name are ETD (Tube, Tympanostomy, 2); QJA (Tympanostomy Tube Delivery Product With Drug, 1).
Next steps
- See all 2 Tusker Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETD, Tusker Medical, Inc.'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.