Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sonomed, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
104 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171098 | AXIS Image Management System | Sonomed, Inc. | 2017-05-02 | 19 | 0 |
| K140199 | VUPAD | Sonomed, Inc. | 2014-04-01 | 64 | 0 |
| K100252 | MASTER-VU A-SCAN, MV4500 | Sonomed, Inc. | 2010-04-09 | 71 | 0 |
| K092637 | PACSCAN PLUS, MODELS 300P AND 300AP | Sonomed, Inc. | 2009-09-24 | 28 | 0 |
| K073196 | MASTER-VU | Sonomed, Inc. | 2007-12-19 | 36 | 0 |
| K060626 | VUMAX | Sonomed, Inc. | 2006-04-11 | 33 | 0 |
| K040668 | E-Z SCAN AB5500+ | Sonomed, Inc. | 2004-04-13 | 29 | 0 |
| K924311 | SONOMED 4000P ULTRASONIC PACHYMETER | Sonomed, Inc. | 1992-12-08 | 104 | 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