Thornhill Research, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Thornhill Research, Inc.” (first 2010, latest 2017), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 247 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 140 |
| 2015 | 1 | 336 |
| 2016 | 0 | — |
| 2017 | 1 | 379 |
| 2018 | 0 | — |
| 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, 510(k)s cleared under the name Thornhill Research, Inc. took a median 379 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 255 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 3 | 3 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| QFB | Isocapnic Ventilation Device | 1 | 0 |
Review panels
- Anesthesiology (5)
Most recent Thornhill Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161420 | MOVES SLC | BTL | 2017-06-06 | 379 |
| K140264 | MADM | BSZ | 2015-01-05 | 336 |
| K140049 | MOVES SLC | BTL | 2014-05-29 | 140 |
| K093261 | MOVES | BTL | 2010-03-26 | 158 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170044 | De Novo | Isocapnic Ventilation Device | 2019-03-14 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-11-19.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Thornhill Research, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Thornhill Research, Inc.” (first 2010, latest 2017), plus 1 De Novo decision, across 3 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 Thornhill Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thornhill Research, Inc. is 247 days.
Which FDA product codes appear under Thornhill Research, Inc.?
The most frequent FDA product codes under this applicant name are BTL (Ventilator, Emergency, Powered (Resuscitator), 3); BSZ (Gas-Machine, Anesthesia, 1); QFB (Isocapnic Ventilation Device, 1).
Next steps
- See all 4 Thornhill Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTL, Thornhill Research, 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.