510(k) · Cleared
ClearedPanthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panthera Production AB · IOR Wheelchair, Mechanical
Cleared on Jan 26, 2009 as substantially equivalent to K012167 (Invacare Corp., 2001) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1992. 4 later devices descend from it.
- Decided
- Jan 26, 2009
- Review
- 84 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922535 (1992). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
- 2 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- 1 generation backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- This deviceK083231 Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009
- Descendant · cites it directly · 2 of its ownK220698 Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023
- Descendant · 2 generations on · 1 of its ownK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025
- Descendant · 3 generations on · 0 of its ownK260121 Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK123076 Profthand Mechanical WheelchairHarmony Hill International · 2013
Most influential descendants
Showing 4 of 4 · See all- K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023 · cites it directly2descendants
- K243111Bowhead ERA WheelchairsBowhead Design Corp. · 2025 · 2 generations on1descendant
- K260121Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026 · 3 generations on0descendants
- K123076Profthand Mechanical WheelchairHarmony Hill International · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922535 | The Terminator | Top End Wheelchair Sports, Inc. | 1992 | — |
| −2 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| −1 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| 0 (this device) | K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT | Panthera Production AB | 2009 | — |
| +1 | K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023 | — |
| +2 | K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 | — |
| +3 | K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K123076 | Profthand Mechanical Wheelchair | Harmony Hill International | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K012167 | Model Top End Terminator Titanium Manual WheelchairSummary page 2…e the capability of operating a mechanical wheelchair Section 5 3 - Predicate Devices 5 3 1 - Invacare Top End Terminator Titanium wheelchair (ref K01 2167) 5 3 2 - Invacare Top End Terminator SS wheelchair (ref K990157) Section 5 4 - Safety and Effectiveness… | 2001 |
| * | K990157 | Model Top End Terminator SS Manual WheelchairSummary page 2…3 - Predicate Devices 5 3 1 - Invacare Top End Terminator Titanium wheelchair (ref K01 2167) 5 3 2 - Invacare Top End Terminator SS wheelchair (ref K990157) Section 5 4 - Safety and Effectiveness By definition, a device issubstantially equivalent to a predicate d… | 1999 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K220698 (Panthera AB, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K012167.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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/K083231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083231: Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083231
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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