510(k) · Cleared
ClearedKi Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ki Mobility, LLC · IOR Wheelchair, Mechanical
Cleared on Sep 5, 2023 as substantially equivalent to K181090 (Invacare Corporation, 2018) and 1 other predicate after a 1,278-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 5, 2023
- Review
- 1,278 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941989 (1994). 7 ancestors in all, the oldest K934646 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK941989 Action at Manual WheelchairNvacare Corp. · 1994
- 3 generations backK984447 Model Action at II Manual WheelchairInvacare Corp. · 1999 · Recalled
- 2 generations backK012370 Solara JR. Manual WheelchairInvacare Corp. · 2001 · Recalled
- 1 generation backK181090 Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation · 2018
- This deviceK200583 Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLKi Mobility, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941989 | Action at Manual Wheelchair | Nvacare Corp. | 1994 | — |
| −3 | K984447 | Model Action at II Manual Wheelchair | Invacare Corp. | 1999 | 1 |
| −2 | K012370 | Solara JR. Manual Wheelchair | Invacare Corp. | 2001 | 3 |
| −1 | K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | Invacare Corporation | 2018 | — |
| 0 (this device) | K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsSummary page 4…Class: Class I Product Code: IOR Equivalence Claimed to Predicate Device The Ki Mobility Focus CR is equivalent to the Invacare (K181090), manufactured by Invacare Corporation. The reference device for this submission is Quickie IRIS (K123975). Focus 510… | 2018 |
| * | K123975 | Quickie & Zippie SeriesSummary page 4…The Ki Mobility Focus CR is equivalent to the Invacare (K181090), manufactured by Invacare Corporation. The reference device for this submission is Quickie IRIS (K123975). Focus 510(k) Summary I. Predicate Devices Invacare Solara 3G manual wheelchair, K181090 and Sunrise Medical,… | 2013 |
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 29 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Ki Mobility Focus CR manual wheelchair is a manually operated device with wheels that is intended to provide
mobility to adults restricted to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200583: Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200583
Report an extraction error
Are you the manufacturer?
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