510(k) · Cleared
ClearedBTL-199
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · QPL Electromagnetic Stimulator, Pain Relief
Cleared on Aug 7, 2025 as substantially equivalent to K233364 (Neuralace Medical, Inc., 2024) and 1 other predicate after a 185-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Aug 7, 2025
- Review
- 185 days
- Class
- Class II
- Product code
- QPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K984142 (1999). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 6 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 5 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- 4 generations backK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- 3 generations backK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
- 2 generations backK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- 1 generation backK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023
- This deviceK250309 BTL-199BTL Industries, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −6 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| −5 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| −4 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| −3 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| −2 | K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021 | — |
| −1 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100… | Tonica Elektronik A/S | 2023 | — |
| 0 (this device) | K250309 | BTL-199 | BTL Industries, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPL device
- #1 K230014 MagVenture Pain Therapy: MagPro R30, MagPro…score 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233364 | Axon TherapySummary page 6…Device name: MagVenture Pain Therapy Original 510(k) Sponsor: NeuraLace Medical Inc. Original 510(k) Sponsor: Tonica Elektronik A/S 510(k) Number: K233364 510(k) Number: K230014 Product Description The BTL-199 is an electromagnetic stimulator that delive… | 2024 |
| * | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Summary page 6…apy Original 510(k) Sponsor: NeuraLace Medical Inc. Original 510(k) Sponsor: Tonica Elektronik A/S 510(k) Number: K233364 510(k) Number: K230014 Product Description The BTL-199 is an electromagnetic stimulator that delivers brief, focused electromagnetic pulses to non- inv… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All QPL devicesQPL Electromagnetic Stimulator, Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QPL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPL
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPL
No recall names QPL since 2007.
Adverse event reports per year · QPL
1in 2021
MAUDE reports naming product code QPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 185 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250309: BTL-199.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250309
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026