Class Class II
BTL-199 (K250309)
Description
BTL-199 by BTL Industries, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250309
Clearance Date2025-08-07
Clearance TypeTraditional
Product CodeQPL
Regulation Number882.5890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250309
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. BTL-199 (K250309) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024 |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOpt... | Tonica Elektronik A/S | 2023 |
Trace the full predicate network for K250309
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.