510(k) · Cleared
ClearedQuickie Suspension Wheelchair Series Model XTR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical, Inc. · IOR Wheelchair, Mechanical
Cleared on Oct 5, 1998 after a 40-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Oct 5, 1998
- Review
- 40 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK982989 Quickie Suspension Wheelchair Series Model XTRSunrise Medical, Inc. · 1998
- Descendant · cites it directly · 12 of its ownK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- Descendant · 2 generations on · 11 of its ownK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- Descendant · 2 generations on · 4 of its ownK083231 Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009
- Descendant · 3 generations on · 4 of its ownK051369 Syryker Sorano WheelchairStryker Canada · 2005
- Descendant · 3 generations on · 2 of its ownK220698 Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K990157Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999 · cites it directly12descendants
- K012167Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001 · 2 generations on11descendants
- K083231Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009 · 2 generations on4descendants
- K051369Syryker Sorano WheelchairStryker Canada · 2005 · 3 generations on4descendants
- K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982989 | Quickie Suspension Wheelchair Series Model XTR | Sunrise Medical, Inc. | 1998 | — |
| +1 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| +2 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| +2 | K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT | Panthera Production AB | 2009 | — |
| +3 | K051369 | Syryker Sorano Wheelchair | Stryker Canada | 2005 | — |
| +3 | K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | — | Quickie GPS by Sunrise Medical Named without a submission number | |
| * | — | Action A4 by Invacare Corporation Named without a submission number | |
| * | — | Barracuda by Everest & Jennings Named without a submission number | |
| * | — | Boing by Colours Named without a submission number |
What descends from it? (14)
See all 142 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, K990157 (Invacare Corp., 1999) has gone furthest, with 12 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 | — |
What is it indicated for?
Sunrise mechanical wheelchairs empower physically challenged persons by providing a means of mobility.
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as:
Arthritis; Tetraplegic; Multiple Sclerosis
Amputee; Quadriplegic; Polio
Paraplegic; Spina Bifida; Geriatric conditions
Cerebral Palsy; Head Injury or Trauma; And other immobilizeing or debilitating conditions
Hemiplegic; Muscular Dystrophy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982989 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982989: Quickie Suspension Wheelchair Series Model XTR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982989
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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