# K250309: BTL-199

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Aug 7, 2025 after 185 days
- Product code: QPL (Electromagnetic Stimulator, Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K984142 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233364: Axon Therapy, Neuralace Medical, Inc. (2024) Summary page 6.
- K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, Tonica Elektronik A/S (2023) Summary page 6.

## Indications for use
The BTL-199 is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The BTL-199 is for use on patients 18 and older.

Source page: https://510kreport.com/device/K250309
Methodology: https://510kreport.com/methodology