510(k) · Cleared
ClearedHelio Kids; Apex P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Composites · IOR Wheelchair, Mechanical
Cleared on May 28, 2026 as substantially equivalent to K120628 (Motion Composites, 2012) and 3 other predicates after a 119-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- May 28, 2026
- Review
- 119 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K850536 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850536 | Quickie Wheelchairs | Motion Designs, Inc. | 1985 | — |
| −2 | K120628 | HELIO | Motion Composites | 2012 | — |
| −1 | K161425 | APEX Manual Wheelchair | Motion Composites | 2016 | — |
| 0 (this device) | K260295 | Helio Kids; Apex P | Motion Composites | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K120628 | HELIOSummary page 5…Predicate #2 Secondary Predicate Trade name Helio C2, Helio A7 Apex A, Apex C Ki Mobility Spark 510(k) K120628, K143101 K161425 K223527 Manufacturer Motion Composites Motion Composite… | 2012 |
| * | K143101 | Helio A7 Manual Wheelchair, Move Manual WheelchairSummary page 5…e #2 Secondary Predicate Trade name Helio C2, Helio A7 Apex A, Apex C Ki Mobility Spark 510(k) K120628, K143101 K161425 K223527 Manufacturer Motion Composites Motion Composites… | 2015 |
| * | K161425 | APEX Manual WheelchairSummary page 5…edicate Trade name Helio C2, Helio A7 Apex A, Apex C Ki Mobility Spark 510(k) K120628, K143101 K161425 K223527 Manufacturer Motion Composites Motion Composites Ki Mobility LLC… | 2016 |
| * | K223527 | Little Wave Clik, Rogue XP, Little Wave XP, SparkSummary page 5…Helio C2, Helio A7 Apex A, Apex C Ki Mobility Spark 510(k) K120628, K143101 K161425 K223527 Manufacturer Motion Composites Motion Composites Ki Mobility LLC Class… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K120628.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Helio Kids:
The Helio Kids is indicated as a manual wheelchair to provide mobility for pediatric persons (23 kg to 75 kg) limited to a sitting position.
Apex P:
The Apex P is indicated as a manual wheelchair to provide mobility for pediatric persons (23 kg to 75 kg) limited to a sitting position.
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/K260295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260295: Helio Kids; Apex P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260295
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026