510(k) · Cleared
ClearedAlpha Control Liner System (ACLS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt · GXY Electrode, Cutaneous
Cleared on Jan 11, 2023 as substantially equivalent to K191083 (Coapt, LLC, 2019) after a 28-day review. Its family tree reaches back 4 generations to 2003. 2 later devices descend from it.
- Decided
- Jan 11, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032833 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK032833 Myosystem with CustomizingOtto Bock Healthcare LP · 2003
- 3 generations backK123795 Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
- 2 generations backK162891 Complete Control SystemCoapt, LLC · 2017
- 1 generation backK191083 COMPLETE CONTROL System Gen2Coapt, LLC · 2019
- This deviceK223738 Alpha Control Liner System (ACLS)Coapt · 2023
- Descendant · cites it directly · 1 of its ownK242326 Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032833 | Myosystem with Customizing | Otto Bock Healthcare LP | 2003 | — |
| −3 | K123795 | Axon-Bus Prosthetic System | Otto Bock Austria | 2014 | — |
| −2 | K162891 | Complete Control System | Coapt, LLC | 2017 | — |
| −1 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019 | — |
| 0 (this device) | K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 | — |
| +1 | K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025 | — |
| +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 | 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? (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 |
|---|---|---|---|
| * | K191083 | COMPLETE CONTROL System Gen2Summary page 5…10(k) Premarket Submission Alpha Control Liner 4. Legally Marketed Predicate Device 510(k) Number Device Name K191083 Coapt Complete Control System Gen2 5. Device Description The Alpha Control Liner System is an interf… | 2019 |
| † | K162891 | Complete Control System | 2017 |
| † | K190416 | Dome Electrode | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | 2025 | 1 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K242326 (Bionit Labs Srl, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223738: Alpha Control Liner System (ACLS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223738
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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