Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trokamed GmbH — 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) |
|---|---|---|---|---|---|
| K200770 | Mini PCNL-System | Trokamed GmbH | 2021-07-30 | 492 | 4 |
| K091010 | TROKAMED MORCELLATOR | Trokamed GmbH | 2011-03-01 | 691 | 1 |
| K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | Trokamed GmbH | 2006-07-19 | 170 | 0 |
| K060232 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES | Trokamed GmbH | 2006-07-12 | 163 | 10 |
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