Class Class II
Klaxon (Twist); Klaxon (Twist R) (K240267)
Description
Klaxon (Twist); Klaxon (Twist R) by Klaxon Mobility GmbH, an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240267
Clearance Date2025-01-10
Clearance TypeTraditional
Product CodeITI
Regulation Number890.3860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240267
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Klaxon (Twist); Klaxon (Twist R) (K240267) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192016 | SMOOV O10 | Alber GmbH | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250748 | KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH | 2025 |
Trace the full predicate network for K240267
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.