510(k) · Cleared
Recalled · 2003Power Wheelchair - Tilt & Recline Seating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tarsys Engineering, Inc. · ITI Wheelchair, Powered
Cleared on May 29, 1991 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- May 29, 1991
- Review
- 75 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK911151 Power Wheelchair - Tilt & Recline Seating SystemTarsys Engineering, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK991119 Tilt/Recliner for Power Wheelchairs, Model 2GInvacare Corp. · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK050264 Stealth Products Seating SystemStealth Products · 2005
- Descendant · 2 generations on · 0 of its ownK033819 Invacare 3G TarsysInvacare Corp. · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911151 | Power Wheelchair - Tilt & Recline Seating System | Tarsys Engineering, Inc. | 1991 | — |
| +1 | K991119 | Tilt/Recliner for Power Wheelchairs, Model 2G | Invacare Corp. | 1999 | 1 |
| +2 | K050264 | Stealth Products Seating System | Stealth Products | 2005 | — |
| +2 | K033819 | Invacare 3G Tarsys | Invacare Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991119 | Tilt/Recliner for Power Wheelchairs, Model 2G | 1999 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2003 | Not classified | Z-0682-03 | Other | A short circuit within the charger harness may cause heat damage to the units with potential for fire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991119 (Invacare Corp., 1999) has gone furthest, with 2 descendants 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/K911151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K911151: Power Wheelchair - Tilt & Recline Seating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K911151
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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