510(k) · Cleared

Cleared

Quickie TSR

K952641510(k) TraditionalCleared Jul 6, 199527-day reviewClass I21 CFR 890.3850

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

Sunrise Medical, Inc. · IOR Wheelchair, Mechanical

Cleared on Jul 6, 1995 after a 27-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it.

Decided: Jul 6, 1995
Review: 27 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 0

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

This deviceK952641 Quickie TSRSunrise Medical, Inc. · 1995
Descendant · cites it directly · 13 of its ownK984447 Model Action at II Manual WheelchairInvacare Corp. · 1999 · Recalled
Descendant · 2 generations on · 6 of its ownK012370 Solara JR. Manual WheelchairInvacare Corp. · 2001 · Recalled
Descendant · 2 generations on · 4 of its ownK063736 Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 2007 · Recalled
Descendant · 3 generations on · 2 of its ownK043332 Wheelchair, Model 8500-IICycling and Health Tech. Industry R&D Center · 2004
Descendant · 2 generations on · 1 of its ownK181090 Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1999high 2 (2003) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all

K984447Model Action at II Manual WheelchairInvacare Corp. · 1999 · cites it directly13descendants
K012370Solara JR. Manual WheelchairInvacare Corp. · 2001 · 2 generations on6descendants
K063736Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 2007 · 2 generations on4descendants
K043332Wheelchair, Model 8500-IICycling and Health Tech. Industry R&D Center · 2004 · 3 generations on2descendants
K181090Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation · 2018 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952641	Quickie TSR	Sunrise Medical, Inc.	1995	—
+1	K984447	Model Action at II Manual Wheelchair	Invacare Corp.	1999	1
+2	K012370	Solara JR. Manual Wheelchair	Invacare Corp.	2001	3
+2	K063736	Fuze Mechanical Wheelchair, Models T20 and T50	Pdg Product Design Group, Inc.	2007	1
+3	K043332	Wheelchair, Model 8500-II	Cycling and Health Tech. Industry R&D Center	2004	—
+2	K181090	Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs	Invacare Corporation	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2003	2	0
2004	1	0
2007	2	0
2008	2	0
2010	2	0
2012	1	0
2013	2	0
2016	1	0
2018	1	0
2023	1	0

FIG. 1 — Lineage of K952641, 1995–2023Source: 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 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K984447	Model Action at II Manual Wheelchair	Invacare Corp.	1999	13
K032402	Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,	Convaid Products, Inc.	2003	1
K101719	Tacamo Manual Wheelchair	Dalton Instrument Corp.	2010	0
K033125	Handivipp	Handinor USA, Inc.	2003	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, K984447 (Invacare Corp., 1999) has gone furthest, with 13 descendants of its own.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOR

17so far in 2026, the most since 2007

2007high 17 (2026) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOR

91in 2025

2007high 233 (2013) · low 32 (2008)2026

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

Recalls per year · IOR

1in 2021

2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · IOR

135in 2025

2007high 5,082 (2014) · low 36 (2007)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	—

https://510kreport.com/device/K952641 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952641: Quickie TSR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952641

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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