510(k) · Cleared
ClearedAxon Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuralace Medical, Inc. · QPL Electromagnetic Stimulator, Pain Relief
Cleared on Jun 11, 2021 as substantially equivalent to K181688 (Shenzhen Roundwhale Technology Co., Ltd., 2018) after a 158-day review. Its family tree reaches back 5 generations to 1999. 5 later devices descend from it.
- Decided
- Jun 11, 2021
- Review
- 158 days
- Class
- Class II
- Product code
- QPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K984142 (1999). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 4 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 3 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- 2 generations backK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- 1 generation backK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
- This deviceK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023
- Descendant · cites it directly · 1 of its ownK233364 Axon TherapyNeuralace Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250309 BTL-199BTL Industries, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250286 Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2…The Magstim Company Limited · 2025
- Descendant · 2 generations on · 0 of its ownK241785 StarFormer (M008-3T)Fotona D.O.O. · 2025
Most influential descendants
Showing 5 of 5 · See all- K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S · 2023 · cites it directly3descendants
- K233364Axon TherapyNeuralace Medical, Inc. · 2024 · cites it directly1descendant
- K250309BTL-199BTL Industries, Inc. · 2025 · 2 generations on0descendants
- K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…The Magstim Company Limited · 2025 · 2 generations on0descendants
- K241785StarFormer (M008-3T)Fotona D.O.O. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −4 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| −3 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| −2 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| −1 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| 0 (this device) | 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 | — |
| +1 | K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024 | — |
| +2 | K250309 | BTL-199 | BTL Industries, Inc. | 2025 | — |
| +2 | K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim… | The Magstim Company Limited | 2025 | — |
| +2 | K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorSummary page 4…ON The Axon Therapy is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K181688 R-C1 TENS and EMS Stimulator; R-E1 EMS Stimulator; R-T1 TENS Stimulator / Shenzhen… | 2018 |
| † | K973929 | Neotonus MS-101 Magnetic Muscle Stimulator System | 1998 |
| † | K160280 | MagPro R20 | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K230014 (Tonica Elektronik A/S, 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All QPL devicesQPL Electromagnetic Stimulator, Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 and older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210021: Axon Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210021
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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