Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Danmeter A/S — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042315 | CEREBRAL STATE MONITOR - CSM | Danmeter A/S | 2005-01-21 | 148 | 0 |
| K032954 | ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 | Danmeter A/S | 2004-08-09 | 322 | 0 |
| K032955 | AUTOMOVE, MODEL AM800 | Danmeter A/S | 2003-12-15 | 84 | 0 |
| K032988 | ELPHA 4 CONTI | Danmeter A/S | 2003-12-03 | 70 | 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