510(k) · Cleared
ClearedModels Phoenix and Concept 45 Manual Mechanical Wheelchairs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · IOR Wheelchair, Mechanical
Cleared on Mar 20, 1995 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 20, 1995
- Review
- 7 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK951138 Models Phoenix and Concept 45 Manual Mechanical WheelchairsInvacare Corp. · 1995
- Descendant · cites it directly · 2 of its ownK061010 Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato…Future Mobility Healthcare, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK221435 Supertilt Plus (STP)Power Plus Mobility · 2022
- Descendant · 2 generations on · 0 of its ownK103073 Super Chair for Kids by OrionFuture Mobility Healthcare, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK102031 Galaxy LiteFuture Mobility Healthcare, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K061010Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical WheelchairFuture Mobility Healthcare, Inc. · 2006 · cites it directly2descendants
- K221435Supertilt Plus (STP)Power Plus Mobility · 2022 · cites it directly0descendants
- K103073Super Chair for Kids by OrionFuture Mobility Healthcare, Inc. · 2011 · 2 generations on0descendants
- K102031Galaxy LiteFuture Mobility Healthcare, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951138 | Models Phoenix and Concept 45 Manual Mechanical Wheelchairs | Invacare Corp. | 1995 | — |
| +1 | K061010 | Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical… | Future Mobility Healthcare, Inc. | 2006 | — |
| +1 | K221435 | Supertilt Plus (STP) | Power Plus Mobility | 2022 | — |
| +2 | K103073 | Super Chair for Kids by Orion | Future Mobility Healthcare, Inc. | 2011 | — |
| +2 | K102031 | Galaxy Lite | Future Mobility Healthcare, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K061010 (Future Mobility Healthcare, Inc., 2006) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K951138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951138: Models Phoenix and Concept 45 Manual Mechanical Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951138
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026