510(k) · Cleared
ClearedTitan 3W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tzora Active Systems, Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Feb 2, 2017 as substantially equivalent to K150086 (Tzora Active Systems, Ltd., 2015) after a 314-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Feb 2, 2017
- Review
- 314 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052204 (2006). No later device cites it as a predicate yet.
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.
Planning a device in INI? 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 INI device
- #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 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 |
|---|---|---|---|
| * | K150086 | TitanSummary page 4…to the following devices: Manufacturer Device 510(k) Date Cleared Tzora Active Systems Ltd. Titan 4W K150086 August 5, 2015 5. Device Description The Titan 3W scooter is an electrically powered scooter. It is intended to be used… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 1 company; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · INI
21so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 2025
MAUDE reports naming product code INI, 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 | 29 | 2 | 64 |
| 2008 | 7 | 28 | 0 | 29 |
| 2009 | 12 | 41 | 0 | 25 |
| 2010 | 5 | 46 | 3 | 56 |
| 2011 | 5 | 130 | 3 | 70 |
| 2012 | 1 | — | 0 | 172 |
| 2013 | 2 | — | 1 | 454 |
| 2014 | 1 | — | 0 | 567 |
| 2015 | 9 | 202 | 0 | 151 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 5 | 191 | 0 | 45 |
| 2018 | 3 | 266 | 0 | 51 |
| 2019 | 4 | 298 | 0 | 25 |
| 2020 | 1 | — | 0 | 26 |
| 2021 | 5 | 575 | 0 | 41 |
| 2022 | 6 | 159 | 0 | 41 |
| 2023 | 9 | 123 | 0 | 32 |
| 2024 | 8 | 137 | 0 | 31 |
| 2025 | 15 | 111 | 0 | 26 |
| 2026 | 21 | 108 | 0 | — |
What is it indicated for?
The Titan 3W is a mobility assistive device for indoor and outdoor use on mild terrain. It
is not used as a transportation vehicle on roads and freeways used by cars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160835: Titan 3W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160835
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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