Timex Medical Products Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Timex Medical Products Corp.” (first 1982, latest 1984), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
- Cardiovascular (3)
- Clinical Chemistry (1)
- General Hospital (1)
Most recent Timex Medical Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841616 | TIMEX HEALTHCHECK DIGITAL BP MONITOR | DXN | 1984-06-05 | 35 |
| K841595 | HEALTHCHECK HOME PREGNANCY TEST KIT | LCX | 1984-05-31 | 43 |
| K840228 | HEALTHCHECK AUTO INFLATE DIGITAL BP | DXN | 1984-05-09 | 110 |
| K821437 | DIGITAL BLOOD PRESSURE METER | DXN | 1982-05-28 | 15 |
| K821436 | ELECTRONIC DIGITAL THERMOMETER | FLL | 1982-05-27 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Timex Medical Products Corp..
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 Timex Medical Products Corp.?
FDA lists 5 510(k) clearances under the applicant name “Timex Medical Products Corp.” (first 1982, latest 1984), across 3 product codes in 3 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 Timex Medical Products Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Timex Medical Products Corp. is 35 days.
Which FDA product codes appear under Timex Medical Products Corp.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); FLL (Continuous Measurement Thermometer, 1); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 1).
Next steps
- See all 5 Timex Medical Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Timex Medical Products Corp.'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.