510(k) · Cleared
ClearedModel Int/DL40I Micro Computer Controller for Power Wheelchairs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · ITI Wheelchair, Powered
Cleared on Aug 7, 1995 after a 172-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 7, 1995
- Review
- 172 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK950724 Model Int/DL40I Micro Computer Controller for Power WheelchairsInvacare Corp. · 1995
- Descendant · cites it directly · 1 of its ownK970094 Model DX Micro Computer ControlInvacare Respiratory Corp. · 1997
- Descendant · 2 generations on · 0 of its ownK072475 Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option)Etac Sverige AB · 2007
- Descendant · cites it directly · 0 of its ownK073134 A-Series Integral Controller, Model Int/DL40IInvacare Corporation · 2007
Most influential descendants
Showing 3 of 3 · See all- K970094Model DX Micro Computer ControlInvacare Respiratory Corp. · 1997 · cites it directly1descendant
- K072475Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option)Etac Sverige AB · 2007 · 2 generations on0descendants
- K073134A-Series Integral Controller, Model Int/DL40IInvacare Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950724 | Model Int/DL40I Micro Computer Controller for Power Wheelchairs | Invacare Corp. | 1995 | — |
| +1 | K970094 | Model DX Micro Computer Control | Invacare Respiratory Corp. | 1997 | — |
| +2 | K072475 | Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option) | Etac Sverige AB | 2007 | — |
| +1 | K073134 | A-Series Integral Controller, Model Int/DL40I | Invacare Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITI? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K970094 (Invacare Respiratory Corp., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K950724 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950724: Model Int/DL40I Micro Computer Controller for Power Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950724
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026