Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medsonics — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770904 | PROBE, BLOOD FLOW DETECTOR PLUG-IN | Medsonics | 1977-05-26 | 10 | 0 |
| K770332 | AMPLIFIER, PHOTOPULSE, MODEL PA13 | Medsonics | 1977-02-24 | 7 | 0 |
| K760751 | CONTINUOUS WAVE DOPPLER | Medsonics | 1976-10-13 | 12 | 0 |
| K760728 | CONTINUOUS WAVE DOPPLER ULTRASOUND | Medsonics | 1976-10-06 | 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