510(k) · Cleared
ClearedMyosystem with Customizing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Healthcare LP · GXY Electrode, Cutaneous
Cleared on Sep 23, 2003 after a 12-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 14 later devices descend from it.
- Decided
- Sep 23, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
14 later devices descend from it, 1 citing it directly.
- This deviceK032833 Myosystem with CustomizingOtto Bock Healthcare LP · 2003
- Descendant · cites it directly · 13 of its ownK123795 Axon-Bus Prosthetic SystemOtto Bock Austria · 2014
- Descendant · 2 generations on · 7 of its ownK162891 Complete Control SystemCoapt, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK220002 Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 2022
- Descendant · 3 generations on · 3 of its ownK191083 COMPLETE CONTROL System Gen2Coapt, LLC · 2019
- Descendant · 4 generations on · 2 of its ownK223738 Alpha Control Liner System (ACLS)Coapt · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123795Axon-Bus Prosthetic SystemOtto Bock Austria · 2014 · cites it directly13descendants
- K162891Complete Control SystemCoapt, LLC · 2017 · 2 generations on7descendants
- K220002Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 2022 · 2 generations on3descendants
- K191083COMPLETE CONTROL System Gen2Coapt, LLC · 2019 · 3 generations on3descendants
- K223738Alpha Control Liner System (ACLS)Coapt · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032833 | Myosystem with Customizing | Otto Bock Healthcare LP | 2003 | — |
| +1 | K123795 | Axon-Bus Prosthetic System | Otto Bock Austria | 2014 | — |
| +2 | K162891 | Complete Control System | Coapt, LLC | 2017 | — |
| +2 | K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Zhejiang Qiangnao Technology Co.,Ltd | 2022 | — |
| +3 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | 2019 | — |
| +4 | K223738 | Alpha Control Liner System (ACLS) | Coapt | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K032933 | MyoSystem Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…mal Limb Prosthetic Component GX\/H [3) £95. 1320 C. Identification of Legally Marketed Devices L 2. Name: K Number: 3. Date Cleared: MyoSystem Exermnpt Exempt k032933 510(k) SUMMARY 3 QUALITY FOR LIFE North American Headquarters Two Cardson Parkway N.. Suite 1C Minnezpolis, MN $5447-4467 Pho… |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123795 | Axon-Bus Prosthetic System | 2014 | 13 |
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?
- Of its descendants, K123795 (Otto Bock Austria, 2014) has gone furthest, with 13 descendants 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.
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?
Adult External Electric Upper Extremity System
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/K032833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032833: Myosystem with Customizing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032833
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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