Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Verathon Incorporated — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
97 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172356 | BladderScan Prime PLUS System | Verathon Incorporated | 2017-09-15 | 43 | 0 |
| K153101 | BladderScan Prime System | Verathon Incorporated | 2015-11-19 | 24 | 0 |
| K090214 | VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND | Verathon Incorporated | 2009-03-13 | 43 | 1 |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | Verathon Incorporated | 2008-12-01 | 97 | 2 |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | Verathon Incorporated | 2007-05-17 | 15 | 1 |
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