Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sonomed Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
531 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931908 | SONOQUICK ULTRASOUND GEL | Sonomed Technology, Inc. | 1994-09-29 | 531 | 0 |
| K931909 | CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL | Sonomed Technology, Inc. | 1994-09-29 | 531 | 0 |
| K883917 | NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT | Sonomed Technology, Inc. | 1989-03-31 | 196 | 0 |
| K844031 | SONOMED TECH OPHTHALMIC B-SCAN B-3000 | Sonomed Technology, Inc. | 1985-05-22 | 219 | 0 |
| K843696 | OPHTHALMIC A-SCAN A-2000 SONOME | Sonomed Technology, Inc. | 1985-02-26 | 160 | 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