Huestis Machine Corp.: FDA clearances and approvals
Huestis Machine Corp. has 7 FDA 510(k) clearances (first 1980, latest 2018), across 5 product codes in 1 review panel. Median 510(k) review time: 92 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 63 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Huestis Machine Corp.'s cleared 510(k)s took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | 2 | 2 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
Review panels
- Radiology (7)
Most recent Huestis Machine Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181874 | MX40 Mobile Digital X-ray System | IZL | 2018-09-14 | 63 |
| K940145 | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE | IYE | 1995-01-24 | 386 |
| K926187 | POSICAST IMMOBILIZATION SYSTEM | IYE | 1994-04-15 | 493 |
| K904005 | HUESTIS FLEXI-BOARD | JAD | 1990-11-29 | 92 |
| K901567 | THE HUESTIS COMPU-PLOTTER | IXI | 1990-05-31 | 58 |
| K880047 | HUESTIS COMPU-FORMER | IXI | 1988-04-11 | 96 |
| K792721 | HUESTIS FLEXI-HOLDER | IXA | 1980-02-19 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Huestis Machine 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 Huestis Machine Corp. have?
Huestis Machine Corp. has 7 FDA 510(k) clearances (first 1980, latest 2018), across 5 product codes in 1 review panel.
How long does FDA take to clear Huestis Machine Corp.'s 510(k)s?
The median time from FDA receipt to decision across Huestis Machine Corp.'s cleared 510(k)s is 92 days.
What devices does Huestis Machine Corp. make?
Its most frequent FDA product codes are IXI (Block, Beam-Shaping, Radiation Therapy, 2); IYE (Accelerator, Linear, Medical, 2); IXA (Cassette, Radiographic Film, 1).
Has Huestis Machine Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Huestis Machine Corp. Related entities may recall under other names.
Next steps
- See all 7 Huestis Machine Corp. clearances with predicates and recalls
- Run predicate analysis for product code IXI, Huestis Machine 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.