510(k) · Cleared
ClearedComplete Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt, LLC · GXY Electrode, Cutaneous
Cleared on Apr 14, 2017 as substantially equivalent to K123795 (Otto Bock Austria, 2014) after a 179-day review. Its family tree reaches back 2 generations to 2003. 7 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 179 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032833 (2003). 7 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 deviceK162891 Complete Control SystemCoapt, LLC · 2017
- Descendant · cites it directly · 3 of its ownK191083 COMPLETE CONTROL System Gen2Coapt, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK223738 Alpha Control Liner System (ACLS)Coapt · 2023
- Descendant · cites it directly · 2 of its ownK182112 Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK242326 Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025
- Descendant · 2 generations on · 1 of its ownK191179 Myo PlusOtto Bock Healthcare Products GmbH · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191083COMPLETE CONTROL System Gen2Coapt, LLC · 2019 · cites it directly3descendants
- K223738Alpha Control Liner System (ACLS)Coapt · 2023 · 2 generations on2descendants
- K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018 · cites it directly2descendants
- K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl · 2025 · 3 generations on1descendant
- K191179Myo PlusOtto Bock Healthcare Products GmbH · 2019 · 2 generations on1descendant
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) | K162891 | Complete Control System | Coapt, LLC | 2017 | — |
| +1 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019 | — |
| +2 | K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 | — |
| +1 | K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018 | — |
| +3 | K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025 | — |
| +2 | K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 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…Z, Hand, External Limb Component, Powered Device Class: Class II Classification Panel: Neurology 5. Legally Marketed Predicate Device(s) K123795, Otto Bock Health Care Product GmbH Axon Bus Prosthetic System 6. Indication for Use Statement The COMPLETE CONTROL System i… | 2014 |
What descends from it? (7)
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 14 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, K191083 (Coapt, LLC, 2019) has gone furthest, with 3 descendants 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. 2017, 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 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/K162891 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162891: Complete Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162891
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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