Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Stim A/S · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040228 | MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 | Medi-Stim A/S | 2004-04-29 | 87 | 0 |
| K992305 | MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 | Medi-Stim A/S | 1999-09-08 | 62 | 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