Dannik: FDA clearances and approvals
Dannik has 8 FDA 510(k) clearances (first 2019, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 93 days. Since 2017 its median was 93 days, against 107 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 70 |
| 2020 | 3 | 102 |
| 2021 | 2 | 188 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 27 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dannik's cleared 510(k)s took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| FZP | Clip, Implantable | 1 | 1 |
Review panels
Most recent Dannik 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | GCJ | 2025-03-12 | 27 |
| K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | GEI | 2021-10-28 | 206 |
| K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable Handles | GEI | 2021-08-16 | 171 |
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | GEI | 2020-06-09 | 49 |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) | GCJ | 2020-04-21 | 102 |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | GEI | 2020-03-04 | 127 |
| K192711 | Dannik Titanium Ligation Clip | FZP | 2019-12-20 | 84 |
| K192643 | Dannik Laparoscopic Suction Irrigation System | GCJ | 2019-11-19 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Dannik.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dannik have?
Dannik has 8 FDA 510(k) clearances (first 2019, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Dannik's 510(k)s?
The median time from FDA receipt to decision across Dannik's cleared 510(k)s is 93 days. Since 2017: 93 days, versus 107 days for all cleared 510(k)s in the same product codes.
What devices does Dannik make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GCJ (Laparoscope, General & Plastic Surgery, 3); FZP (Clip, Implantable, 1).
Has Dannik had device recalls?
openFDA lists no recalls under a recalling firm name matching Dannik. Related entities may recall under other names.
Next steps
- See all 8 Dannik clearances with predicates and recalls
- Run predicate analysis for product code GEI, Dannik's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.