510(k) · Cleared
ClearedIcon Adult Manual
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icon Wheelchairs, Inc. · IOR Wheelchair, Mechanical
Cleared on May 3, 2011 as substantially equivalent to K082970 (Rogue Wheels, Inc., 2008) after a 25-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- May 3, 2011
- Review
- 25 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922535 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
- 4 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- 3 generations backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- 2 generations backK051369 Syryker Sorano WheelchairStryker Canada · 2005
- 1 generation backK082970 Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008
- This deviceK110985 Icon Adult ManualIcon Wheelchairs, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK140023 ElevationPdg Product Design Group, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140023ElevationPdg Product Design Group, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922535 | The Terminator | Top End Wheelchair Sports, Inc. | 1992 | — |
| −4 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| −3 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| −2 | K051369 | Syryker Sorano Wheelchair | Stryker Canada | 2005 | — |
| −1 | K082970 | Marvel Wheelchair, Model EDCAL01 | Rogue Wheels, Inc. | 2008 | — |
| 0 (this device) | K110985 | Icon Adult Manual | Icon Wheelchairs, Inc. | 2011 | — |
| +1 | K140023 | Elevation | Pdg Product Design Group, Inc. | 2014 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082970 | Marvel Wheelchair, Model EDCAL01Summary page 1…890.3850 ,duct Codle(s) IOR Legally marketed dlevice(s) Marvel Wheelchair model K082970 to which equivalence is claimed Reason for 51 0(k) The Icon Adult Manual Wheelchair is a new device.… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140023 | Elevation | 2014 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140023 (Pdg Product Design Group, Inc., 2014) has gone furthest, with 0 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. 2011, this device’s year, is highlighted.
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 Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide
mobility to persons with disabilities restricted to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110985: Icon Adult Manual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110985
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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