Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medwave, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
102 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061557 | FUSION | Medwave, Inc. | 2006-09-15 | 102 | 0 |
| K053185 | PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM | Medwave, Inc. | 2006-01-24 | 71 | 0 |
| K011152 | VASOTRAC APM205A | Medwave, Inc. | 2001-05-31 | 45 | 0 |
| K001898 | VASOTRAX | Medwave, Inc. | 2000-08-31 | 70 | 0 |
| K950249 | VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205 | Medwave, Inc. | 1995-02-01 | 12 | 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