510(k) · Cleared
ClearedInvacare 3G Tarsys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · ITI Wheelchair, Powered
Cleared on Jun 4, 2004 as substantially equivalent to K991119 (Invacare Corp., 1999) and 2 other predicates after a 178-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jun 4, 2004
- Review
- 178 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K972563 (1997). 11 ancestors in all, the oldest K911151 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK972563 Lift MasterMechanical Application Designs, Inc. · 1997
- 2 generations backK992828 E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320…Accelerated Rehab Designs, Inc. · 2000
- 1 generation backK013516 Invacare Elevating Seat Option ESS6Invacare Corp. · 2001
- This deviceK033819 Invacare 3G TarsysInvacare Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972563 | Lift Master | Mechanical Application Designs, Inc. | 1997 | — |
| −2 | K992828 | E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-EP320, Ard-Elancer | Accelerated Rehab Designs, Inc. | 2000 | — |
| −1 | K013516 | Invacare Elevating Seat Option ESS6 | Invacare Corp. | 2001 | — |
| 0 (this device) | K033819 | Invacare 3G Tarsys | Invacare Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K991119 | Tilt/Recliner for Power Wheelchairs, Model 2GSummary page 2…cts that are substantially equivalent to the Seat Option ESS6 (K013516, Invacare 2G Tarsys (K991119. August 19, 1999), the Invacare Elevating System w… | 1999 |
| * | K013516 | Invacare Elevating Seat Option ESS6Summary page 2…Substantial Equivalence: Products that are substantially equivalent to the Seat Option ESS6 (K013516, Invacare 2G Tarsys (K991119. August 19, 1999), the Invacare Elevating… | 2001 |
| * | K021264 | TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and…Summary page 2…Positioning July 30, 2002). Gravity Shifting Power Tilt. Recline and Power Elevating Seat (K021264, designed for use with powered Each of these produ… | 2002 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K991119.
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 fruction of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate f1metion is intended primarily to provide powered elevation of the wheelchair seat and user in order to assist tLhe user wit1i daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tilt-only and recline only versions are rated for a combined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033819: Invacare 3G Tarsys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033819
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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