510(k) · Cleared
ClearedMyOnyx System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thought Technology, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Jun 17, 2022 as substantially equivalent to K171978 (Shenzhen Dongdixin Technology Co., Ltd., 2017) after a 261-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jun 17, 2022
- Review
- 261 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K984142 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 3 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 2 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- 1 generation backK171978 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator…Shenzhen Dongdixin Technology Co., Ltd. · 2017
- This deviceK213197 MyOnyx SystemThought Technology, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −3 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| −2 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| −1 | K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K213197 | MyOnyx System | Thought Technology, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10Summary page 4…ectiveness information to provide an understanding of the basis for a determination of substantial equivalence. Predicate Device: Combo Stimulator MT9000 (K171978, Product Codes: IPF, GZJ) Reference Device: MyOnyx System (K201014, Product codes: KPI, HCC) Indications for Us… | 2017 |
| † | K201014 | MyOnyx System | 2021 |
| † | K132422 | Pals Platinum Neurostimulation Electrodes | 2014 |
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 23 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K171978.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213197: MyOnyx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213197
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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