Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cma Microdialysis AB · 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) |
|---|---|---|---|---|---|
| K102077 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2011-01-14 | 175 | 0 |
| K071984 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2008-06-27 | 344 | 0 |
| K060554 | CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2006-05-02 | 62 | 0 |
| K020285 | CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2002-10-23 | 268 | 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