510(k) · Cleared
ClearedQuickie QX Manual Folding Wheelchair
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 Sep 10, 2007 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 10, 2007
- Review
- 38 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK072153 Quickie QX Manual Folding WheelchairSunrise Medical, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK133855 Breezy EleganceSunrise Medical (Us), LLC · 2014
- Descendant · 2 generations on · 0 of its ownK162328 Winner Transfer WheelchairWinner SG Pte, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK082246 Dignity 100Dignity Medical Devices, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072153 | Quickie QX Manual Folding Wheelchair | Sunrise Medical, Inc. | 2007 | — |
| +1 | K133855 | Breezy Elegance | Sunrise Medical (Us), LLC | 2014 | — |
| +2 | K162328 | Winner Transfer Wheelchair | Winner SG Pte, Ltd. | 2017 | — |
| +1 | K082246 | Dignity 100 | Dignity Medical Devices, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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, K133855 (Sunrise Medical (Us), LLC, 2014) has gone furthest, with 1 descendant 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. 2007, 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 Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair's intended use is to provide mobility to persons restricted to a sitting position.
The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels that is intended for medical purposes which provides an optional means of mobility for physically challenged people
The mechanical wheelchair is indicated for physically challenged individuals and can provide a means of mobility.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072153: Quickie QX Manual Folding Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072153
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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