510(k) · Cleared
ClearedAPEX Manual Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Composites · IOR Wheelchair, Mechanical
Cleared on Dec 5, 2016 as substantially equivalent to K123975 (Sunrise Medical, 2013) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- Dec 5, 2016
- Review
- 196 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850536 (1985). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK850536 Quickie WheelchairsMotion Designs, Inc. · 1985
- 1 generation backK120628 HELIOMotion Composites · 2012
- This deviceK161425 APEX Manual WheelchairMotion Composites · 2016
- Descendant · cites it directly · 1 of its ownK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025
- Descendant · cites it directly · 0 of its ownK260295 Helio Kids; Apex PMotion Composites · 2026
- Descendant · 2 generations on · 0 of its ownK260121 Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026
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 |
|---|---|---|---|---|---|
| −2 | K850536 | Quickie Wheelchairs | Motion Designs, Inc. | 1985 | — |
| −1 | K120628 | HELIO | Motion Composites | 2012 | — |
| 0 (this device) | K161425 | APEX Manual Wheelchair | Motion Composites | 2016 | — |
| +1 | K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 | — |
| +1 | K260295 | Helio Kids; Apex P | Motion Composites | 2026 | — |
| +2 | K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K123975 | Quickie & Zippie SeriesSummary page 4…chair, Mechanical (21 CFR 890.3850) Regulatory Class: I Product Code: IOR III. PREDICATE DEVICE Sunrise Medical Quickie Q7 Manual Wheelchair K123975 Helio C2 Manual Wheelchair K120628 IV. DEVICE DESCRIPTION The Motion Composites APEX Manual Wheelchair is m… | 2013 |
| * | K120628 | HELIOSummary page 4…Regulatory Class: I Product Code: IOR III. PREDICATE DEVICE Sunrise Medical Quickie Q7 Manual Wheelchair K123975 Helio C2 Manual Wheelchair K120628 IV. DEVICE DESCRIPTION The Motion Composites APEX Manual Wheelchair is manually operated, user propelled, m… | 2012 |
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?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 27.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243111 (Bowhead Design Corp., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K123975.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161425: APEX Manual Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161425
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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