Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dannik — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
127 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | 2020-06-09 | 49 | 0 |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, | Dannik | 2020-04-21 | 102 | 0 |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | 2020-03-04 | 127 | 0 |
| K192711 | Dannik Titanium Ligation Clip | Dannik | 2019-12-20 | 84 | 0 |
| K192643 | Dannik Laparoscopic Suction Irrigation System | Dannik | 2019-11-19 | 56 | 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