510(k) · Cleared
ClearedSunrunner TE-777
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pride Health Care, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on Jul 17, 1992 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 46 later devices descend from it.
- Decided
- Jul 17, 1992
- Review
- 17 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 3 citing it directly.
- This deviceK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- Descendant · cites it directly · 42 of its ownK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- Descendant · 2 generations on · 40 of its ownK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- Descendant · 3 generations on · 37 of its ownK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- Descendant · 4 generations on · 36 of its ownK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- Descendant · 5 generations on · 35 of its ownK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K012791C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001 · cites it directly42descendants
- K031272C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003 · 2 generations on40descendants
- K032919C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003 · 3 generations on37descendants
- K070603C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007 · 4 generations on36descendants
- K162952C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017 · 5 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| +1 | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| +2 | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| +3 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| +4 | K070603 | C.T.M. Mobilitty Scooter # HS-295 | C.T.M. Homecare Product, Inc. | 2007 | — |
| +5 | K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in INI? 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 INI device
- #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (46)
See all 463 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?
- Of its descendants, K012791 (Warepalmy Enterprise, LLC (Usa), 2001) has gone furthest, with 42 descendants of its own.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · INI
21so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 2025
MAUDE reports naming product code INI, 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 | 29 | 2 | 64 |
| 2008 | 7 | 28 | 0 | 29 |
| 2009 | 12 | 41 | 0 | 25 |
| 2010 | 5 | 46 | 3 | 56 |
| 2011 | 5 | 130 | 3 | 70 |
| 2012 | 1 | — | 0 | 172 |
| 2013 | 2 | — | 1 | 454 |
| 2014 | 1 | — | 0 | 567 |
| 2015 | 9 | 202 | 0 | 151 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 5 | 191 | 0 | 45 |
| 2018 | 3 | 266 | 0 | 51 |
| 2019 | 4 | 298 | 0 | 25 |
| 2020 | 1 | — | 0 | 26 |
| 2021 | 5 | 575 | 0 | 41 |
| 2022 | 6 | 159 | 0 | 41 |
| 2023 | 9 | 123 | 0 | 32 |
| 2024 | 8 | 137 | 0 | 31 |
| 2025 | 15 | 111 | 0 | 26 |
| 2026 | 21 | 108 | 0 | — |
https://510kreport.com/device/K923193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923193: Sunrunner TE-777.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923193
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026