510(k) · Cleared
ClearedWHILL (WHILL Model C2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Whill, Inc. · ITI Wheelchair, Powered
Cleared on Jun 12, 2026 as substantially equivalent to K213383 (Whill, Inc., 2021) after a 63-day review. Its family tree reaches back 8 generations to 1997. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 12, 2026
- Review
- 63 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K960951 (1997). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 7 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- 6 generations backK041219 ElectroPermobil AB · 2004 · Recalled
- 5 generations backK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- 4 generations backK103477 Permobil M300 / M400Permobil AB · 2011
- 3 generations backK143180 F3Permobil AB · 2015
- 2 generations backK153543 WHILL Model MWhill, Inc. · 2016
- 1 generation backK213383 WHILL Model C2Whill, Inc. · 2021 · Recalled (Class I)
- This deviceK261175 WHILL (WHILL Model C2)Whill, Inc. · 2026
Class I recalls in this family
- K213383 WHILL Model C2direct predicate · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −7 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| −6 | K041219 | Electro | Permobil AB | 2004 | 4 |
| −5 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| −4 | K103477 | Permobil M300 / M400 | Permobil AB | 2011 | — |
| −3 | K143180 | F3 | Permobil AB | 2015 | — |
| −2 | K153543 | WHILL Model M | Whill, Inc. | 2016 | — |
| −1 | K213383 | WHILL Model C2 | Whill, Inc. | 2021 | Class I |
| 0 (this device) | K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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.
1 device in this family has a Class I recall. 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213383 | WHILL Model C2Summary page 5…3860 Product Code(s) ITI | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K213383 WHILL Model C2 ITl Device Description Summary 21 CFR 807.92(a)(4) (K213383). Major Design Change (Risk Level Impacting) from… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K213383WHILL Model C2Whill, Inc. · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K213383.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor
mobility to persons limited to a seated position that are capable of operating a powered
wheelchair.
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/K261175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261175: WHILL (WHILL Model C2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261175
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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