Tdk Corp.: FDA clearances and approvals
Tdk Corp. has 6 FDA 510(k) clearances (first 1984, latest 1988), across 2 product codes in 1 review panel. Median 510(k) review time: 87 days.
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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 5 | 5 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Tdk Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883643 | TDK ECG ELECTRODE, MEL-10L | DRX | 1988-11-17 | 86 |
| K882904 | TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 | DRX | 1988-10-05 | 85 |
| K870834 | TDK ECG ELECTRODE MEL-10 | DRX | 1987-03-23 | 20 |
| K863369 | MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES | DRX | 1987-01-06 | 166 |
| K854596 | TDK ECG ELECTRODE MEL-08-09 & -11 | DRS | 1986-05-07 | 170 |
| K833899 | TDK ECG ELECTRODE MEL-08 | DRX | 1984-02-10 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Tdk 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 Tdk Corp. have?
Tdk Corp. has 6 FDA 510(k) clearances (first 1984, latest 1988), across 2 product codes in 1 review panel.
How long does FDA take to clear Tdk Corp.'s 510(k)s?
The median time from FDA receipt to decision across Tdk Corp.'s cleared 510(k)s is 87 days.
What devices does Tdk Corp. make?
Its most frequent FDA product codes are DRX (Electrode, Electrocardiograph, 5); DRS (Transducer, Blood-Pressure, Extravascular, 1).
Has Tdk Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tdk Corp. Related entities may recall under other names.
Next steps
- See all 6 Tdk Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Tdk 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.