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 Jan 10, 2024 as substantially equivalent to K210021 (Neuralace Medical, Inc., 2021) after a 100-day review. Its family tree reaches back 6 generations to 1999. 1 later device descends from it.
- Decided
- Jan 10, 2024
- Review
- 100 days
- Class
- Class II
- Product code
- QPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K984142 (1999). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 5 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 4 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- 3 generations backK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- 2 generations backK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
- 1 generation backK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- This deviceK233364 Axon TherapyNeuralace Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250309 BTL-199BTL Industries, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250309BTL-199BTL Industries, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −5 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| −4 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| −3 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| −2 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| −1 | K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021 | — |
| 0 (this device) | K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024 | — |
| +1 | K250309 | BTL-199 | BTL Industries, Inc. | 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 |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K210021 | Axon TherapySummary page 5…he Axon Therapy is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K210021 Axon Therapy / NeuraLace The predicate device has not been subject to a d… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250309 | BTL-199 | 2025 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K250309 (BTL Industries, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K210021.
How does its category compare?
All QPL devicesQPL Electromagnetic Stimulator, Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on 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/K233364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233364: Axon Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233364
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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