Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Klaxon-Mobility GmbH — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250748 | KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH | 2025-04-11 | 30 | 0 |
| K240267 | Klaxon (Twist); Klaxon (Twist R) | Klaxon Mobility GmbH | 2025-01-10 | 345 | 0 |
| K222502 | KLICK (VARIANTS: POWER, RACE, MONSTER) | Klaxon Mobility GmbH | 2022-12-16 | 120 | 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