510(k) · Cleared

Cleared

Legend SC 300

K926295510(k) TraditionalCleared Mar 28, 1994469-day reviewClass II21 CFR 890.3800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pride Health Care, Inc. · INI Vehicle, Motorized 3-Wheeled

Cleared on Mar 28, 1994 after a 469-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Mar 28, 1994
Review: 469 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 0

7 later devices descend from it, 4 citing it directly.

This deviceK926295 Legend SC 300Pride Health Care, Inc. · 1994
Descendant · cites it directly · 2 of its ownK072165 Victory Three Wheel Scooter, Model: SC610Pride Mobility Products Corp. · 2007 · Recalled
Descendant · cites it directly · 1 of its ownK971043 Golden EagleGolden Technologies, Inc. · 1997
Descendant · 2 generations on · 0 of its ownK110567 C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK090805 V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter…Pride Mobility Products Corp. · 2009
Descendant · 2 generations on · 0 of its ownK032879 Navigator IAdaptive Healthcare Technologies, Inc. · 2003

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1997high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 7 · See all

K072165Victory Three Wheel Scooter, Model: SC610Pride Mobility Products Corp. · 2007 · cites it directly2descendants
K971043Golden EagleGolden Technologies, Inc. · 1997 · cites it directly1descendant
K110567C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc. · 2011 · 2 generations on0descendants
K090805V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10…Pride Mobility Products Corp. · 2009 · 2 generations on0descendants
K032879Navigator IAdaptive Healthcare Technologies, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K926295	Legend SC 300	Pride Health Care, Inc.	1994	—
+1	K072165	Victory Three Wheel Scooter, Model: SC610	Pride Mobility Products Corp.	2007	2
+1	K971043	Golden Eagle	Golden Technologies, Inc.	1997	—
+2	K110567	C.T.M. Mobility Scooter HS515(3W)	C.T.M. Homecare Product, Inc.	2011	—
+2	K090805	V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model…	Pride Mobility Products Corp.	2009	—
+2	K032879	Navigator I	Adaptive Healthcare Technologies, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
2003	1	0
2007	1	0
2009	1	0
2011	1	0

FIG. 1 — Lineage of K926295, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072165	Victory Three Wheel Scooter, Model: SC610	Pride Mobility Products Corp.	2007	2
K971043	Golden Eagle	Golden Technologies, Inc.	1997	1
K983407	Aceme Jupiter Scooter, 4-Wheeled,Model Jupiter 50F	Aceme Technologies Intl.	1998	0
K983405	Aceme Jupiter Scooter, 3-Wheeled, Model Jupiter 50	Aceme Technologies Intl.	1998	0

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, K072165 (Pride Mobility Products Corp., 2007) has gone furthest, with 2 descendants of its own.

How does its category compare?

All INI devices

INI 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

2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007high 575 (2021) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · INI

1in 2013

2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INI

26in 2025

2007high 567 (2014) · low 25 (2009)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/K926295 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926295: Legend SC 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926295

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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