Hamilton Thorne Biosciences: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Hamilton Thorne Biosciences” (first 2005, latest 2007), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| MRX | System, Assisted Reproduction Laser | 3 | 2 |
Review panels
Most recent Hamilton Thorne Biosciences 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063636 | ZILOS-TK | MRX | 2007-04-24 | 138 |
| K050768 | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | MRX | 2005-04-28 | 34 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN040009 | De Novo | System, Assisted Reproduction Laser | 2004-11-04 |
Recalls
openFDA lists no recalls under a recalling firm named Hamilton Thorne Biosciences.
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 Research (5 510(k)s)
- Hamilton Thorne, Inc. (4 510(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 Biosciences?
FDA lists 2 510(k) clearances under the applicant name “Hamilton Thorne Biosciences” (first 2005, latest 2007), plus 1 De Novo decision, across 1 product code 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 Hamilton Thorne Biosciences?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hamilton Thorne Biosciences is 86 days.
Which FDA product codes appear under Hamilton Thorne Biosciences?
The most frequent FDA product codes under this applicant name are MRX (System, Assisted Reproduction Laser, 3).
Next steps
- See all 2 Hamilton Thorne Biosciences clearances with predicates and recalls
- Run predicate analysis for product code MRX, Hamilton Thorne Biosciences'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.