510(k) · Cleared
ClearedK-Tech 2 Power Tilt Seating System, Model K2PT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Track Corporation · ITI Wheelchair, Powered
Cleared on Oct 31, 2003 as substantially equivalent to K981837 (Motion Concepts, 1998) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 31, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972564 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972564 Tilt Master CG System (Center of Gravity), Tilt-N-Space-SeatMechanical Application Designs, Inc. · 1997
- This deviceK033263 K-Tech 2 Power Tilt Seating System, Model K2PTTrack Corporation · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972564 | Tilt Master CG System (Center of Gravity), Tilt-N-Space-Seat | Mechanical Application Designs, Inc. | 1997 | — |
| 0 (this device) | K033263 | K-Tech 2 Power Tilt Seating System, Model K2PT | Track Corporation | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K981837 | TRX-CG Center-of-Gravity Shifting Power Tilt and Recline SystemsSummary page 2…Number: 890.3860 Type: Traditional 14 Substantial Equivalence: K981837: Motion Concepts, TRx-CG Center of Gravity Shifting Power Tilt K972564:… | 1998 |
| * | K972564 | Tilt Master CG System (Center of Gravity), Tilt-N-Space-SeatSummary page 2…ge 2 === Substantial Equivalence: K981837: Motion Concepts, TRx-CG Center of Gravity Shifting Power Tilt K972564: Tiltmaster Center of Gravity Power Tilt System Description: The Track Corporation K-Tech Power Tilt Seat… | 1997 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K981837.
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 K-Tech 2 is appropriate for use by individuals that use a power wheelchair for mobility and require positioning changes without the aid of an attendant. These positioning changes are needed for, but not limited to:
Comfort for increased sitting tolerance
Positioning to increase upper body stability
Pressure relief or reduction to shift the end user's body weight from the buttocks to the back
Track Corporation makes no claims as to the therapeutic effectiveness of this device. our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033263: K-Tech 2 Power Tilt Seating System, Model K2PT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033263
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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