Hdx Will Corp.: FDA clearances and approvals
Hdx Will Corp. has 9 FDA 510(k) clearances (first 2016, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time: 189 days. Since 2017 its median was 149 days, against 116 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 253 |
| 2017 | 1 | 109 |
| 2018 | 2 | 218 |
| 2019 | 2 | 60 |
| 2020 | 0 | — |
| 2021 | 3 | 245 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hdx Will Corp.'s cleared 510(k)s took a median 149 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (9)
Most recent Hdx Will Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211159 | eco-x Series (eco-x, eco-x-s) | OAS | 2021-12-30 | 255 |
| K211114 | Will3D | LLZ | 2021-12-15 | 245 |
| K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | OAS | 2021-10-19 | 92 |
| K192700 | Xcam | EHD | 2019-12-27 | 92 |
| K190357 | Star-X, Intraoral X-ray System | EHD | 2019-03-15 | 28 |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | MUH | 2018-11-21 | 189 |
| K172168 | WillCeph | LLZ | 2018-03-21 | 246 |
| K170180 | Will3D | LLZ | 2017-05-08 | 109 |
| K160140 | DENTRIa series | OAS | 2016-09-30 | 253 |
Recalls
openFDA lists no recalls under a recalling firm named Hdx Will Corp..
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 Hdx Will Corp. have?
Hdx Will Corp. has 9 FDA 510(k) clearances (first 2016, latest 2021), across 4 product codes in 1 review panel.
How long does FDA take to clear Hdx Will Corp.'s 510(k)s?
The median time from FDA receipt to decision across Hdx Will Corp.'s cleared 510(k)s is 189 days. Since 2017: 149 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Hdx Will Corp. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 3); OAS (X-Ray, Tomography, Computed, Dental, 3); EHD (Unit, X-Ray, Extraoral With Timer, 2).
Has Hdx Will Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hdx Will Corp. Related entities may recall under other names.
Next steps
- See all 9 Hdx Will Corp. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Hdx Will Corp.'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.