Aktormed GmbH: FDA clearances and approvals
Aktormed GmbH has 5 FDA 510(k) clearances (first 2018, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 300 days. Since 2017 its median was 300 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 449 |
| 2019 | 0 | — |
| 2020 | 1 | 300 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 286 |
| 2025 | 0 | — |
| 2026 | 1 | 69 |
Review time against the same product codes
Since 2017, Aktormed GmbH's cleared 510(k)s took a median 300 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | 2 | 2 |
| QZB | Software Controlled Endoscope And Instrument Holder | 2 | 2 |
| OCV | Endoscope Holder | 1 | 1 |
Review panels
Most recent Aktormed GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261573 | ENDOSCOPE HOLDER (182214) | QZB | 2026-07-20 | 69 |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | QZB | 2024-08-08 | 314 |
| K232405 | ENDOFIX EXO | OCV | 2024-04-25 | 259 |
| K200473 | SoloAsisst II, Voice Control | NAY | 2020-12-22 | 300 |
| K171947 | SOLOASSIST II | NAY | 2018-09-21 | 449 |
Recalls
openFDA lists no recalls under a recalling firm named Aktormed GmbH.
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 Aktormed GmbH have?
Aktormed GmbH has 5 FDA 510(k) clearances (first 2018, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Aktormed GmbH's 510(k)s?
The median time from FDA receipt to decision across Aktormed GmbH's cleared 510(k)s is 300 days. Since 2017: 300 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Aktormed GmbH make?
Its most frequent FDA product codes are NAY (System, Surgical, Computer Controlled Instrument, 2); QZB (Software Controlled Endoscope And Instrument Holder, 2); OCV (Endoscope Holder, 1).
Has Aktormed GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Aktormed GmbH. Related entities may recall under other names.
Next steps
- See all 5 Aktormed GmbH clearances with predicates and recalls
- Run predicate analysis for product code NAY, Aktormed GmbH'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.