510(k) · Cleared
ClearedDexus Prosthetics System (Model: MSL1, MSR1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Qiangnao Technology Co.,Ltd · GXY Electrode, Cutaneous
Cleared on Sep 9, 2022 as substantially equivalent to K123795 (Otto Bock Austria, 2014) after a 248-day review. Its family tree reaches back 2 generations to 2003. 3 later devices descend from it.
- Decided
- Sep 9, 2022
- Review
- 248 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032833 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK032833 Myosystem with CustomizingOtto Bock Healthcare LP · 2003
- 1 generation backK123795 Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
- This deviceK220002 Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 2022
- Descendant · cites it directly · 1 of its ownK242326 Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025
- Descendant · cites it directly · 0 of its ownK262654 Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026
- Descendant · 2 generations on · 0 of its ownK260453 Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl · 2026
Most influential descendants
Showing 3 of 3 · See all- K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025 · cites it directly1descendant
- K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026 · cites it directly0descendants
- K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032833 | Myosystem with Customizing | Otto Bock Healthcare LP | 2003 | — |
| −1 | K123795 | Axon-Bus Prosthetic System | Otto Bock Austria | 2014 | — |
| 0 (this device) | K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | 2022 | — |
| +1 | K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025 | — |
| +1 | K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | 2026 | — |
| +2 | K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 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 |
|---|---|---|---|
| * | K123795 | Axon-Bus Prosthetic SystemSummary page 5…Powered, External Upper Limb Prosthetic System 1/7 Classification Name: Cutaneous Electrode 510(K) Number: K123795 Review Panel: Neurology Product Code: GXY, IQZ Regulation Number: 21 CFR 882.1320 Regulation Class: II 4. Device Description Th… | 2014 |
What descends from it? (3)
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 19 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K242326 (Bionit Labs Srl, 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K123795.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.
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/K220002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220002: Dexus Prosthetics System (Model: MSL1, MSR1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220002
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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