Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & W Medico Teknik A/S — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964593 | DIASCOPE TRAVELLER PLUS (4053) | S & W Medico Teknik A/S | 1997-06-30 | 227 | 0 |
| K942196 | 3050 DIASCOPE NT PATIENT MONITOR | S & W Medico Teknik A/S | 1995-06-28 | 420 | 0 |
| K934887 | 9750 ATHENA ETHERNET OPTION | S & W Medico Teknik A/S | 1994-01-14 | 94 | 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