Class Class II
UniBur (K252662)
Description
UniBur by Nakanishi, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252662
Clearance Date2025-09-19
Clearance TypeTraditional
Product CodeHBE
Regulation Number882.4310
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252662
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. UniBur (K252662) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026 |
Trace the full predicate network for K252662
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.