De Novo · Granted
GrantedARC-EX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onward Medical, Inc. · SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Granted on Dec 19, 2024 as a new device type through De Novo after a 266-day review. 3 later devices descend from it.
- Decided
- Dec 19, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- SDO
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN240014 ARC-EX SystemOnward Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253638 xStep (xStep)Spinex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252893 ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System…Aneuvo · 2026
- Descendant · cites it directly · 0 of its ownK251821 ARC-EX SystemOnward Medical, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240014 | ARC-EX System | Onward Medical, Inc. | 2024 | — |
| +1 | K253638 | xStep (xStep) | Spinex, Inc. | 2026 | — |
| +1 | K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011)… | Aneuvo | 2026 | — |
| +1 | K251821 | ARC-EX System | Onward Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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 SDO? 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 SDO device
- #1 K253638 xStep (xStep)score 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 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?
- Of its descendants, K253638 (Spinex, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SDO devicesSDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SDO
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SDO
Too few SDO 510(k)s in any year since 2007 to give a median.
Recalls per year · SDO
No recall names SDO since 2007.
Adverse event reports per year · SDO
No MAUDE report names SDO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240014 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240014: ARC-EX System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240014
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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