Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODX · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130554 | REDSENSE ALARM SYSTEM | Redsense Medical AB | 2013-11-22 | 263 | 0 |
| K103242 | REDSENSE-ALARM UNIT AND SENSOR | Redsense Medical AB | 2011-02-10 | 100 | 0 |
| K092955 | REDSENSE-HOME USE | Redsense Medical AB | 2010-05-10 | 227 | 0 |
| K071013 | REDSENSE | Redsense Medical AB | 2007-10-18 | 191 | 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