510(k) · Cleared
ClearedRenegade Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha One · IQC Wheelchair, Special Grade
Cleared on Jan 6, 2009 as substantially equivalent to K051369 (Stryker Canada, 2005) and 1 other predicate after a 99-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jan 6, 2009
- Review
- 99 days
- Class
- Class II
- Product code
- IQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922535 (1992). 6 ancestors in all, the oldest K840631 (1984). No later device cites it as a predicate yet.
- Root · 4 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
- 3 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- 2 generations backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- 1 generation backK051369 Syryker Sorano WheelchairStryker Canada · 2005
- This deviceK082857 Renegade WheelchairAlpha One · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922535 | The Terminator | Top End Wheelchair Sports, Inc. | 1992 | — |
| −3 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| −2 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| −1 | K051369 | Syryker Sorano Wheelchair | Stryker Canada | 2005 | — |
| 0 (this device) | K082857 | Renegade Wheelchair | Alpha One | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 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 IQC? 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 IQC device
- #1 K251570 Hippocampe Marathon and Trailscore 10.5 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K051369 | Syryker Sorano Wheelchair | 2005 |
| * | K840631 | Arnas WheelchairSummary page 1…cial Grade Product Codes: IOR and IQC Predicate Devices: Stryker Sorano Wheelchair (KO5i1369) Poirier S.A. Arnas Wheelchair (K840631) Statement of Intended The Renegade Wheelchair is a versatile, mechanical Use: wheelchair intended for… | 1984 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K051369.
How does its category compare?
All IQC devicesIQC Wheelchair, Special Grade: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IQC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IQC
Too few IQC 510(k)s in any year since 2007 to give a median.
Recalls per year · IQC
No recall names IQC since 2007.
Adverse event reports per year · IQC
No MAUDE report names IQC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082857: Renegade Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082857
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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