Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HEK — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
176 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | 2015-03-20 | 176 | 0 |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Summit Doppler Systems, Inc. | 2006-04-10 | 53 | 0 |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Advanced Medical Systems, Inc. | 1990-10-22 | 159 | 0 |
| K883334 | BIODOP(TM) | Diagnosis Related Systems, Inc. | 1988-12-15 | 128 | 0 |
| K771211 | DOPPLER (UTD-5 & UTD-6) | Terumo America, Inc. | 1977-07-14 | 9 | 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