510(k) · Cleared
ClearedC.T.M. Mobility Scooter Model # HS-320
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Warepalmy Enterprise, LLC (Usa) · INI Vehicle, Motorized 3-Wheeled
Cleared on Oct 24, 2001 as substantially equivalent to K923193 (Pride Health Care, Inc., 1992) after a 65-day review. Its family tree reaches back 1 generation to 1992. 42 later devices descend from it.
- Decided
- Oct 24, 2001
- Review
- 65 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923193 (1992). 42 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- This deviceK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- Descendant · cites it directly · 40 of its ownK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- Descendant · 2 generations on · 37 of its ownK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- Descendant · 3 generations on · 36 of its ownK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- Descendant · 4 generations on · 35 of its ownK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
- Descendant · 5 generations on · 34 of its ownK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K031272C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003 · cites it directly40descendants
- K032919C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003 · 2 generations on37descendants
- K070603C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007 · 3 generations on36descendants
- K162952C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017 · 4 generations on35descendants
- K182471ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019 · 5 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| 0 (this device) | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| +1 | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| +2 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| +3 | K070603 | C.T.M. Mobilitty Scooter # HS-295 | C.T.M. Homecare Product, Inc. | 2007 | — |
| +4 | K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017 | — |
| +5 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2007 | 3 | 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), 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 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? (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 |
|---|---|---|---|
| * | K923193 | Sunrunner TE-777Summary page 1…890.3800. Legally marketed device for substantial equivalence comparison: Sunrunner TE-777-3 submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) ¥K923193. Description of the device: The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor electric scooter that is battery operated. I… | 1992 |
What descends from it? (42)
See all 422 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?
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 | — |
What is it indicated for?
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides
transportation for disabled or elderly persons.
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/K012791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012791: C.T.M. Mobility Scooter Model # HS-320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012791
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026