510(k) · Cleared
Clearedmyosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Healthcare Products GmbH · GXY Electrode, Cutaneous
Cleared on Apr 22, 2026 as substantially equivalent to K191179 (Otto Bock Healthcare Products GmbH, 2019) and 1 other predicate after a 205-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Apr 22, 2026
- Review
- 205 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. No later device cites it as a predicate yet.
- 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 backK182112 Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018
- 1 generation backK191179 Myo PlusOtto Bock Healthcare Products GmbH · 2019
- This deviceK253256 myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip.…Otto Bock Healthcare Products GmbH · 2026
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 | K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | 2018 | — |
| −1 | K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | 2019 | — |
| 0 (this device) | K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1)… | Otto Bock Healthcare Products GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K191179 | Myo PlusSummary page 5…ectrode Classification Product Code GXY, IQZ Regulation Number 882.1320 510(k) Number K191179 1 K253256 51… | 2019 |
| * | K240884 | Glide (91000-GL-X)Summary page 6…n Product Code GXY, IQZ Regulation Number 882.1320 510(k) Number K240884 6 Indications for Use Statement myosmart is to be used exclusively for exoprosthetic fittings of the upper limbs.… | 2024 |
| † | K123795 | Axon-Bus Prosthetic System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 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.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Myosmart 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/K253256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253256: myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253256
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026