Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aktormed GmbH — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
300 daysmedian FDA review time
449 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261573 | ENDOSCOPE HOLDER (182214) | Aktormed GmbH | 2026-07-20 | 69 | 0 |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo ( | Aktormed GmbH | 2024-08-08 | 314 | 0 |
| K232405 | ENDOFIX EXO | Aktormed GmbH | 2024-04-25 | 259 | 0 |
| K200473 | SoloAsisst II, Voice Control | Aktormed GmbH | 2020-12-22 | 300 | 0 |
| K171947 | SOLOASSIST II | Aktormed GmbH | 2018-09-21 | 449 | 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