510(k) · Cleared
ClearedSmoov O10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alber GmbH · ITI Wheelchair, Powered
Cleared on May 19, 2020 as substantially equivalent to K151199 (Max Mobility, LLC, 2015) after a 295-day review. Its family tree reaches back 1 generation to 2015. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- May 19, 2020
- Review
- 295 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151199 (2015). 6 later devices descend from it, 4 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK151199 SmartDrive Wheelchair Power AssistMax Mobility, LLC · 2015 · Recalled (Class I)
- This deviceK192016 Smoov O10Alber GmbH · 2020
- Descendant · cites it directly · 1 of its ownK240267 Klaxon (Twist); Klaxon (Twist R)Klaxon Mobility GmbH · 2025
- Descendant · cites it directly · 1 of its ownK222502 Klick (Variants: Power, Race, Monster)Klaxon Mobility GmbH · 2022
- Descendant · cites it directly · 1 of its ownK192618 e-Motion M25Alber GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK250748 Klaxon (Twist); Klaxon (Twist R)Klaxon-Mobility GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK241159 Handbike Batec ElectricBatec Mobility, S.L. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K151199 SmartDrive Wheelchair Power Assistdirect predicate · 2015
Most influential descendants
Showing 5 of 6 · See all- K240267Klaxon (Twist); Klaxon (Twist R)Klaxon Mobility GmbH · 2025 · cites it directly1descendant
- K222502Klick (Variants: Power, Race, Monster)Klaxon Mobility GmbH · 2022 · cites it directly1descendant
- K192618e-Motion M25Alber GmbH · 2020 · cites it directly1descendant
- K250748Klaxon (Twist); Klaxon (Twist R)Klaxon-Mobility GmbH · 2025 · 2 generations on0descendants
- K241159Handbike Batec ElectricBatec Mobility, S.L. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151199 | SmartDrive Wheelchair Power Assist | Max Mobility, LLC | 2015 | Class I |
| 0 (this device) | K192016 | Smoov O10 | Alber GmbH | 2020 | — |
| +1 | K240267 | Klaxon (Twist); Klaxon (Twist R) | Klaxon Mobility GmbH | 2025 | — |
| +1 | K222502 | Klick (Variants: Power, Race, Monster) | Klaxon Mobility GmbH | 2022 | — |
| +1 | K192618 | e-Motion M25 | Alber GmbH | 2020 | — |
| +2 | K250748 | Klaxon (Twist); Klaxon (Twist R) | Klaxon-Mobility GmbH | 2025 | — |
| +2 | K241159 | Handbike Batec Electric | Batec Mobility, S.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 3 | 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.
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 |
|---|---|---|---|
| * | K151199 | SmartDrive Wheelchair Power AssistSummary page 4…ormation: We claim substantial equivalence for the subject device SMOOV O10 in intended use, design and function to the predicate device SmartDrive (MX2+) (K151199) by MaxMobility GmbH. Indications for Use: The SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary… | 2015 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. It is 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 as stated in the FDA summary.
https://510kreport.com/device/K192016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192016: Smoov O10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192016
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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