Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tdk Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
170 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883643 | TDK ECG ELECTRODE, MEL-10L | Tdk Corp. | 1988-11-17 | 86 | 0 |
| K882904 | TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 | Tdk Corp. | 1988-10-05 | 85 | 0 |
| K870834 | TDK ECG ELECTRODE MEL-10 | Tdk Corp. | 1987-03-23 | 20 | 0 |
| K863369 | MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES | Tdk Corp. | 1987-01-06 | 166 | 0 |
| K854596 | TDK ECG ELECTRODE MEL-08-09 & -11 | Tdk Corp. | 1986-05-07 | 170 | 0 |
| K833899 | TDK ECG ELECTRODE MEL-08 | Tdk Corp. | 1984-02-10 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda