510(k) · Cleared
Recalled · 2003Tilt/Recliner for Power Wheelchairs, Model 2G
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 19, 1999 as substantially equivalent to K911151 (Tarsys Engineering, Inc., 1991) and 3 other predicates after a 139-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 19, 1999
- Review
- 139 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K911151 (1991). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK911151 Power Wheelchair - Tilt & Recline Seating SystemTarsys Engineering, Inc. · 1991 · Recalled
- This deviceK991119 Tilt/Recliner for Power Wheelchairs, Model 2GInvacare Corp. · 1999
- Descendant · cites it directly · 0 of its ownK050264 Stealth Products Seating SystemStealth Products · 2005
- Descendant · cites it directly · 0 of its ownK033819 Invacare 3G TarsysInvacare Corp. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911151 | Power Wheelchair - Tilt & Recline Seating System | Tarsys Engineering, Inc. | 1991 | 1 |
| 0 (this device) | K991119 | Tilt/Recliner for Power Wheelchairs, Model 2G | Invacare Corp. | 1999 | — |
| +1 | K050264 | Stealth Products Seating System | Stealth Products | 2005 | — |
| +1 | K033819 | Invacare 3G Tarsys | Invacare Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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? (4)
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 |
|---|---|---|---|
| * | K911151 | Power Wheelchair - Tilt & Recline Seating SystemSummary page 2…vider. B. Substantial Equivalence Products which are substantially equivalent to the Invacare Model 2G Tilt/Recline are; Tarsys Engineering Tilt/Recline Seating System (K 911151, March 29, 1991), the Everest & Jennings Power Recliner Wheelchair (K914091, November 19, 1991), the Permobile Chairman (K960951,… | 1991 |
| * | K914091 | Power Recliner WheelchairSummary page 1…tion Name Wheelchair, Powered Predicate Devices Products which are substantially equivalent to the Model 2G Controls are; Everest & Jennings Power Recliner Wheelchair (K914091, November 19, 1991), the Permobile Chairman (K960951, April 30, 1997), and the LaBac Adjustable Sliding Back Power Recline System… | 1991 |
| * | K960951 | Permobil Chairman L/CS 8Summary page 1…ducts which are substantially equivalent to the Model 2G Controls are; Everest & Jennings Power Recliner Wheelchair (K914091, November 19, 1991), the Permobile Chairman (K960951, April 30, 1997), and the LaBac Adjustable Sliding Back Power Recline System (K923363, March 24, 1993). Intended Use Its intende… | 1997 |
| * | K923363 | Adjustable Sliding Back Power Recline SystemSummary page 1…ngs Power Recliner Wheelchair (K914091, November 19, 1991), the Permobile Chairman (K960951, April 30, 1997), and the LaBac Adjustable Sliding Back Power Recline System (K923363, March 24, 1993). Intended Use Its intended function and use is to aid in the pressure relief to persons confined to a powered w… | 1993 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2003 | Not classified | Z-0342-04 | Other | The weld joints on the seat back may fail and cause possible injury to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K050264 (Stealth Products, 2005) has gone furthest, with 0 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 | — |
What is it indicated for?
It is intended use is to aid in the pressure relief of persons confined to a power wheelchair, by providing a method of tilting the seat and reclining the seat back..
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/K991119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991119: Tilt/Recliner for Power Wheelchairs, Model 2G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991119
Report an extraction error
Are you the manufacturer?
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