510(k) · Cleared
ClearedCOMPLETE CONTROL System Gen2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt, LLC · GXY Electrode, Cutaneous
Cleared on May 24, 2019 as substantially equivalent to K162891 (Coapt, LLC, 2017) after a 30-day review. Its family tree reaches back 3 generations to 2003. 3 later devices descend from it.
- Decided
- May 24, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032833 (2003). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK032833 Myosystem with CustomizingOtto Bock Healthcare LP · 2003
- 2 generations backK123795 Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
- 1 generation backK162891 Complete Control SystemCoapt, LLC · 2017
- This deviceK191083 COMPLETE CONTROL System Gen2Coapt, LLC · 2019
- Descendant · cites it directly · 2 of its ownK223738 Alpha Control Liner System (ACLS)Coapt · 2023
- Descendant · 2 generations on · 1 of its ownK242326 Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025
- Descendant · 3 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- K223738Alpha Control Liner System (ACLS)Coapt · 2023 · cites it directly2descendants
- K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025 · 2 generations on1descendant
- K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032833 | Myosystem with Customizing | Otto Bock Healthcare LP | 2003 | — |
| −2 | K123795 | Axon-Bus Prosthetic System | Otto Bock Austria | 2014 | — |
| −1 | K162891 | Complete Control System | Coapt, LLC | 2017 | — |
| 0 (this device) | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019 | — |
| +1 | K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 | — |
| +2 | K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K162891 | Complete Control SystemSummary page 4…s II Classification Panel: Neurology 3. Legally Marketed Predicate Device 510(k) Number Device Name K162891 Coapt Complete Control System 4. Device Description The COMPLETE CONTROL System Gen2 is an advanced… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223738 | Alpha Control Liner System (ACLS) | 2023 | 2 |
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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 COMPLETE CONTROL System Gen2 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/K191083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191083: COMPLETE CONTROL System Gen2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191083
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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