Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isys Medizintechnik GmbH · 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) |
|---|---|---|---|---|---|
| K230130 | Micromate™ Navi+ | Isys Medizintechnik GmbH | 2023-10-10 | 266 | 0 |
| K203720 | MICROMATE | Isys Medizintechnik GmbH | 2021-06-22 | 183 | 0 |
| K131433 | ISYS 1 (U.S),ACCESSORY, NON-STERILE | Isys Medizintechnik GmbH | 2014-03-11 | 298 | 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