510(k) · Cleared
ClearedAtalante X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wandercraft SAS · PHL Powered Exoskeleton
Cleared on Oct 24, 2025 as substantially equivalent to K232077 (Wandercraft SAS, 2023) after a 212-day review. Its family tree reaches back 7 generations to 2014. 1 later device descends from it.
- Decided
- Oct 24, 2025
- Review
- 212 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN130034 (2014). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 6 generations backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 5 generations backK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 4 generations backK171334 IndegoParker Hannifin Corporation · 2017
- 3 generations backK173530 Indego (R)Parker-Hannifin Corporation · 2018
- 2 generations backK221859 AtalanteWandercraft SAS · 2022 · Recalled
- 1 generation backK232077 Atalante XWandercraft SAS · 2023
- This deviceK250904 Atalante XWandercraft SAS · 2025
- Descendant · cites it directly · 0 of its ownK260381 EveWandercraft SAS · 2026
Most influential descendants
Showing 1 of 1 · See all- K260381EveWandercraft SAS · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −6 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −5 | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −4 | K171334 | Indego | Parker Hannifin Corporation | 2017 | — |
| −3 | K173530 | Indego (R) | Parker-Hannifin Corporation | 2018 | — |
| −2 | K221859 | Atalante | Wandercraft SAS | 2022 | 1 |
| −1 | K232077 | Atalante X | Wandercraft SAS | 2023 | — |
| 0 (this device) | K250904 | Atalante X | Wandercraft SAS | 2025 | — |
| +1 | K260381 | Eve | Wandercraft SAS | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PHL? 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 PHL device
- #1 K260381 Evescore 13.9 · 8 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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260381 | Eve | 2026 | 0 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K260381 (Wandercraft SAS, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PHL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHL
177in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHL
6in 2025
MAUDE reports naming product code PHL, 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 | 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 4 | 145 | 0 | 4 |
| 2017 | 2 | — | 1 | 8 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 4 | 110 | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | 177 | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator for the following populations:
* Individuals with hemiplegia due to cerebrovascular accident (CVA)
* Individuals with spinal cord injuries at levels C4 to L5 (SCI)
* Individuals with multiple sclerosis (MS)
The operator must complete a training program prior to use of the device.
Atalante X is intended to be used on adolescents of 18 years and older, and adults able to tolerate a stand-up position.
The device is not intended for sports or stair climbing.
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/K250904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250904: Atalante X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250904
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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