Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Echo Ultrasound — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
168 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924054 | PHONOCARDIOGRAPH | Echo Ultrasound | 1993-01-22 | 163 | 0 |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Echo Ultrasound | 1990-09-19 | 51 | 0 |
| K893225 | COUPLANT WARMING DEVICE | Echo Ultrasound | 1989-10-12 | 168 | 0 |
| K872519 | STERILIZED OMNI GEL | Echo Ultrasound | 1987-08-03 | 39 | 0 |
| K844120 | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | Echo Ultrasound | 1985-01-23 | 92 | 0 |
| K844034 | SONOCARE | Echo Ultrasound | 1985-01-23 | 99 | 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