510(k) · Cleared
ClearedModel DX Micro Computer Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Respiratory Corp. · ITI Wheelchair, Powered
Cleared on May 12, 1997 as substantially equivalent to K940972 (Invacare Corp., 1994) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- May 12, 1997
- Review
- 122 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940972 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK940972 Model MCC - Mkiv Micro Computer ControlsInvacare Corp. · 1994
- This deviceK970094 Model DX Micro Computer ControlInvacare Respiratory Corp. · 1997
- Descendant · cites it directly · 0 of its ownK072475 Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option)Etac Sverige AB · 2007
Most influential descendants
Showing 1 of 1 · See all- K072475Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option)Etac Sverige AB · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940972 | Model MCC - Mkiv Micro Computer Controls | Invacare Corp. | 1994 | — |
| 0 (this device) | K970094 | Model DX Micro Computer Control | Invacare Respiratory Corp. | 1997 | — |
| +1 | K072475 | Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option) | Etac Sverige AB | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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? (2)
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 |
|---|---|---|---|
| * | K940972 | Model MCC - Mkiv Micro Computer ControlsSummary page 1…r, Powered - 89ITI Predicate Devices The Model Dx Micro-Computer Controls are substantially equivalent to Invacare Corporations’ Model MCC MKIV Micro Computer Controls (K940972 June 2, 1994), and Invacare’s Model INT DLA40i Wheelchair control (K950274, August 7, 1995). Intended Use The intended use of t… | 1994 |
| * | K950724 | Model Int/DL40I Micro Computer Controller for Power Wheelchairs Our OCR of the scanned summary read K950274, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Model INT DLA40i Wheelchair control”. | 1995 |
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 |
|---|---|---|---|
| K072475 | Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option) | 2007 | 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?
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 | — |
What is it indicated for?
The intended use of the Model DX Micro-Computer Control is to activate and control power wheelchair motion.
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/K970094 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970094: Model DX Micro Computer Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970094
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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