510(k) · Cleared
ClearedAbility Power Gurney
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gator Custom Mobility, Inc. · ITI Wheelchair, Powered
Cleared on Mar 16, 2005 as substantially equivalent to K022309 (Stryker Corp., 2002) and 1 other predicate after a 167-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Mar 16, 2005
- Review
- 167 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900565 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| −1 | K993413 | Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control | Invacare Corp. | 1999 | 2 |
| 0 (this device) | K042699 | Ability Power Gurney | Gator Custom Mobility, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 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? (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 |
|---|---|---|---|
| * | K022309 | Stryker Powered Wheeled StretcherSummary page 1…r Regulatory Class: Class U Predicate Devices: Products that are substantially equivalent to the Ability Power Gurney are the Stryker Powered Wheeled Stretcher (K022309, August 13, 2002) and the Invacare Storm Series power wheelchair (K993413, October 12, 1999) Intended Use: The intended use of… | 2002 |
| * | K993413 | Storm Series, Power 9000 Series and Power Tiger with Gyroscope ControlSummary page 1…substantially equivalent to the Ability Power Gurney are the Stryker Powered Wheeled Stretcher (K022309, August 13, 2002) and the Invacare Storm Series power wheelchair (K993413, October 12, 1999) Intended Use: The intended use of the Ability Power Gurney is to provide mobility to persons limited to a p… | 1999 |
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 15 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 5 other devices also cite its predicate K022309.
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 indication for use of the Ability Power Gurney is to provide mobility to persons
limited to a prone position, that have the capability of operating a powered wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042699: Ability Power Gurney.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042699
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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