Hamilton Thorne Research: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hamilton Thorne Research” (first 1987, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 87 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| POV | Semen Analysis Device | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Hematology (4)
- Radiology (1)
Most recent Hamilton Thorne Research 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012805 | AUTOMARQER | POV | 2002-03-13 | 204 |
| K000380 | FOTOMASTER | LLZ | 2000-05-03 | 86 |
| K990184 | AUTOMARQER | POV | 1999-03-19 | 58 |
| K920719 | IVOS ANALYZER | GKL | 1992-06-29 | 132 |
| K873172 | HAMILTON-THORN MOTILITY ANALYZER HTM-2000 | GKL | 1987-11-06 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Hamilton Thorne Research.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hamilton Medical AG (30 510(k)s)
- Hamilton Co. (16 510(k)s)
- Hamilton Medical, Inc. (15 510(k)s)
- Hamilton Industries, Inc. (5 510(k)s)
- Hamilton Thorne, Inc. (4 510(k)s)
- Hamilton Thorne Biosciences (2 510(k)s)
- Hamilton Thorne Incorporated (2 510(k)s)
- Hamilton Kent (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hamilton Thorne Research?
FDA lists 5 510(k) clearances under the applicant name “Hamilton Thorne Research” (first 1987, latest 2002), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hamilton Thorne Research?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hamilton Thorne Research is 87 days.
Which FDA product codes appear under Hamilton Thorne Research?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 2); POV (Semen Analysis Device, 2); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 Hamilton Thorne Research clearances with predicates and recalls
- Run predicate analysis for product code GKL, Hamilton Thorne Research'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.