510(k) · Cleared
ClearedEksoNR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekso Bionics, Inc. · PHL Powered Exoskeleton
Cleared on Jun 19, 2020 as substantially equivalent to K161443 (Ekso Bionics, Inc., 2016) after a 106-day review. Its family tree reaches back 3 generations to 2014. 1 later device descends from it.
- Decided
- Jun 19, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130034 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 2 generations backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 1 generation backK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- This deviceK200574 EksoNREkso Bionics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK220988 EksoNREkso Bionics, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220988EksoNREkso Bionics, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −2 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −1 | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| 0 (this device) | K200574 | EksoNR | Ekso Bionics, Inc. | 2020 | — |
| +1 | K220988 | EksoNR | Ekso Bionics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 K250904 Atalante Xscore 15.0 · 7 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 |
|---|---|---|---|
| * | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Summary page 4…on Name: Powered Exoskeleton Device Classification: Class II, 21 CFR 890.3480 Product Code: PHL Legally Marketed K161443, Ekso, Ekso Bionics, Inc. Predicate Device Device Description The Ekso is a powered motorized orthosis. It consists of a fitted… | 2016 |
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 |
|---|---|---|---|
| K220988 | EksoNR | 2022 | 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 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220988 (Ekso Bionics, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K161443.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The EksoNR™ is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations: * Individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm). * Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms). *…
Read the full statement (119 words)
The EksoNR™ is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations:
* Individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm).
* Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms).
* Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the device. The devices are 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/K200574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200574: EksoNR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200574
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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