510(k) · Cleared
ClearedOrion II (Heavy Duty 350 LBS and 500 LBS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Future Mobility Healthcare, Inc. · IOR Wheelchair, Mechanical
Cleared on Jun 4, 2010 after a 29-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Jun 4, 2010
- Review
- 29 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 1 citing it directly.
- This deviceK101277 Orion II (Heavy Duty 350 LBS and 500 LBS)Future Mobility Healthcare, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK170517 Merits Model R106/R136 Rehab WheelchairMerits Healthcare Industries (Suzhou) Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK252828 Manual Wheelchair (W47)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK200466 Manual Wheelchair (Model W28)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK180309 Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K170517Merits Model R106/R136 Rehab WheelchairMerits Healthcare Industries (Suzhou) Co., Ltd. · 2017 · cites it directly3descendants
- K252828Manual Wheelchair (W47)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd. · 2025 · 2 generations on0descendants
- K200466Manual Wheelchair (Model W28)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2021 · 2 generations on0descendants
- K180309Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101277 | Orion II (Heavy Duty 350 LBS and 500 LBS) | Future Mobility Healthcare, Inc. | 2010 | — |
| +1 | K170517 | Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries (Suzhou) Co., Ltd. | 2017 | — |
| +2 | K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd. | 2025 | — |
| +2 | K200466 | Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2021 | — |
| +2 | K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K061010 | FDA’s K061010 is Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170517 | Merits Model R106/R136 Rehab Wheelchair | 2017 | 3 |
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, K170517 (Merits Healthcare Industries (Suzhou) Co., Ltd., 2017) has gone furthest, with 3 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. 2010, 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?
To provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101277: Orion II (Heavy Duty 350 LBS and 500 LBS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101277
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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