510(k) · Cleared
ClearedBambino 3, S3 and S3 Swing, U3 and U3 Light, X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panthera AB · IOR Wheelchair, Mechanical
Cleared on Feb 16, 2023 as substantially equivalent to K083231 (Panthera Production AB, 2009) after a 344-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 16, 2023
- Review
- 344 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922535 (1992). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
- 3 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- 2 generations backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- 1 generation backK083231 Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009
- This deviceK220698 Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023
- Descendant · cites it directly · 1 of its ownK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK260121 Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922535 | The Terminator | Top End Wheelchair Sports, Inc. | 1992 | — |
| −3 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| −2 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| −1 | K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT | Panthera Production AB | 2009 | — |
| 0 (this device) | K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023 | — |
| +1 | K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 | — |
| +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 |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTSummary page 4…Panel: Physical Medicine 5. Legally Marketed Predicate Device Device name: Bambino, S2, S2 Swing, U2, U2 Light 510(k) number: K083231 Manufacturer: Panthera AB The subject devices are modified versions of the predicate devices. The predicate dev… | 2009 |
| † | K161425 | APEX Manual Wheelchair | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243111 | Bowhead ERA Wheelchairs | 2025 | 1 |
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 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K243111 (Bowhead Design Corp., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K083231.
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?
Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for
indoor / outdoor use and intended to provide mobility to persons that have the capability of operating
a mechanical wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220698: Bambino 3, S3 and S3 Swing, U3 and U3 Light, X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220698
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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