Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Artema Medical AB · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
111 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945359 | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | Artema Medical AB | 1995-02-21 | 111 | 0 |
| K912336 | ARTEMA AQUA+ FLEX | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K912333 | ARTEMA AQUA+ | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K912334 | ARTEMA AQUA+ T & TS | Artema Medical AB | 1991-07-26 | 63 | 0 |
| K912335 | ARTEMA AQUA+ N | Artema Medical AB | 1991-07-26 | 63 | 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