510(k) · Cleared
ClearedWave Electrode (AE02-60); Wave Electrode (AE02-50)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionit Labs Srl · GXY Electrode, Cutaneous
Cleared on Jan 2, 2025 as substantially equivalent to K220002 (Zhejiang Qiangnao Technology Co.,Ltd, 2022) and 1 other predicate after a 149-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.
- Decided
- Jan 2, 2025
- Review
- 149 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K032833 (2003). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK032833 Myosystem with CustomizingOtto Bock Healthcare LP · 2003
- 4 generations backK123795 Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
- 3 generations backK162891 Complete Control SystemCoapt, LLC · 2017
- 2 generations backK191083 COMPLETE CONTROL System Gen2Coapt, LLC · 2019
- 1 generation backK223738 Alpha Control Liner System (ACLS)Coapt · 2023
- This deviceK242326 Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025
- Descendant · cites it directly · 0 of its ownK260453 Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl · 2026
Most influential descendants
Showing 1 of 1 · See all- K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032833 | Myosystem with Customizing | Otto Bock Healthcare LP | 2003 | — |
| −4 | K123795 | Axon-Bus Prosthetic System | Otto Bock Austria | 2014 | — |
| −3 | K162891 | Complete Control System | Coapt, LLC | 2017 | — |
| −2 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019 | — |
| −1 | K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 | — |
| 0 (this device) | K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025 | — |
| +1 | K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K220002 | Dexus Prosthetics System (Model: MSL1, MSR1)Summary page 5…mber Predicate Device Device name Manufacturer I - Primary Zhejiang Qiangnao K220002 Dexus Prosthetics System Tec… | 2022 |
| * | K223738 | Alpha Control Liner System (ACLS)Summary page 5…thetics System Technology Co.,Ltd II - Secondary Alpha Control Liner System K223738 Coapt, LLC (ACLS)… | 2023 |
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 |
|---|---|---|---|
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | 2026 | 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 22 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K260453 (Bionit Labs Srl, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K220002.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242326
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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