510(k) · Cleared
ClearedKlaxon (Twist); Klaxon (Twist R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Klaxon-Mobility GmbH · ITI Wheelchair, Powered
Cleared on Apr 11, 2025 as substantially equivalent to K240267 (Klaxon Mobility GmbH, 2025) after a 30-day review. Its family tree reaches back 3 generations to 2015. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 11, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K151199 (2015). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK151199 SmartDrive Wheelchair Power AssistMax Mobility, LLC · 2015 · Recalled (Class I)
- 2 generations backK192016 Smoov O10Alber GmbH · 2020
- 1 generation backK240267 Klaxon (Twist); Klaxon (Twist R)Klaxon Mobility GmbH · 2025
- This deviceK250748 Klaxon (Twist); Klaxon (Twist R)Klaxon-Mobility GmbH · 2025
Class I recalls in this family
- K151199 SmartDrive Wheelchair Power Assist3 generations back · 2015
View FIG. 1 as a table
Line of descent and top descendants
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.
1 device in this family has a Class I recall. 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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 |
|---|---|---|---|
| * | K240267 | Klaxon (Twist); Klaxon (Twist R)Summary page 5…er 890.3860 Product Code(s) Tl I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K240267 TWIST and variant TWIST R ITI Device Description Summary 21 CFR 807.92(a)(4) The device is an add on accessory for manual wheelc… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151199SmartDrive Wheelchair Power AssistMax Mobility, LLC · 2015 · 3 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The TWIST and TWIST R are add-on drive accessories for wheelchairs.
The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.
TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
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/K250748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250748: Klaxon (Twist); Klaxon (Twist R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250748
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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