Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QZB · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261573 | ENDOSCOPE HOLDER (182214) | Aktormed GmbH | 2026-07-20 | 69 | 0 |
| K250984 | Maestro System (REF100) | Moon Surgical | 2025-06-27 | 88 | 0 |
| K242323 | Maestro System (REF100) | Moon Surgical | 2025-03-14 | 220 | 0 |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo ( | Aktormed GmbH | 2024-08-08 | 314 | 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