Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fetzer Medical GmbH & Co. KG · 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) |
|---|---|---|---|---|---|
| K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | 2018-05-08 | 245 | 4 |
| K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | 2017-06-29 | 196 | 0 |
| K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016-09-09 | 151 | 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