510(k) · Cleared
ClearedSyryker Sorano Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Canada · IOR Wheelchair, Mechanical
Cleared on Sep 26, 2005 as substantially equivalent to K012167 (Invacare Corp., 2001) after a 123-day review. Its family tree reaches back 3 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 26, 2005
- Review
- 123 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922535 (1992). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
- 2 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- 1 generation backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- This deviceK051369 Syryker Sorano WheelchairStryker Canada · 2005
- Descendant · cites it directly · 2 of its ownK082970 Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK110985 Icon Adult ManualIcon Wheelchairs, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK140023 ElevationPdg Product Design Group, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK082857 Renegade WheelchairAlpha One · 2009
Most influential descendants
Showing 4 of 4 · See all- K082970Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008 · cites it directly2descendants
- K110985Icon Adult ManualIcon Wheelchairs, Inc. · 2011 · 2 generations on1descendant
- K140023ElevationPdg Product Design Group, Inc. · 2014 · 3 generations on0descendants
- K082857Renegade WheelchairAlpha One · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922535 | The Terminator | Top End Wheelchair Sports, Inc. | 1992 | — |
| −2 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| −1 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| 0 (this device) | K051369 | Syryker Sorano Wheelchair | Stryker Canada | 2005 | — |
| +1 | K082970 | Marvel Wheelchair, Model EDCAL01 | Rogue Wheels, Inc. | 2008 | — |
| +2 | K110985 | Icon Adult Manual | Icon Wheelchairs, Inc. | 2011 | — |
| +3 | K140023 | Elevation | Pdg Product Design Group, Inc. | 2014 | — |
| +1 | K082857 | Renegade Wheelchair | Alpha One | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K012167 | Model Top End Terminator Titanium Manual Wheelchair | 2001 |
What descends from it? (4)
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)
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 13 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082970 (Rogue Wheels, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K012167.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051369 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051369: Syryker Sorano Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051369
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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