510(k) · Cleared

Recalled · Class II · 2012

Model Action at II Manual Wheelchair

K984447510(k) TraditionalCleared Jan 8, 199925-day reviewClass I21 CFR 890.3850Recalls 1

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

Invacare Corp. · IOR Wheelchair, Mechanical

Cleared on Jan 8, 1999 as substantially equivalent to K952641 (Sunrise Medical, Inc., 1995) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1994. 13 later devices descend from it. It has been recalled once.

Decided: Jan 8, 1999
Review: 25 days
Class: Class I
Product code: IOR
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K941989 (1994). 2 ancestors in all. 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK941989 Action at Manual WheelchairNvacare Corp. · 1994
This deviceK984447 Model Action at II Manual WheelchairInvacare Corp. · 1999
Descendant · cites it directly · 6 of its ownK012370 Solara JR. Manual WheelchairInvacare Corp. · 2001 · Recalled
Descendant · cites it directly · 4 of its ownK063736 Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 2007 · Recalled
Descendant · 2 generations on · 2 of its ownK043332 Wheelchair, Model 8500-IICycling and Health Tech. Industry R&D Center · 2004
Descendant · cites it directly · 1 of its ownK181090 Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation · 2018
Descendant · 2 generations on · 1 of its ownK082274 Haida Model HD11 Manual WheelchairJiangyin East China Medical Technology Co., Ltd. · 2008

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2001high 2 (2008) · low 0 (2002)2026

Most influential descendants

Showing 5 of 13 · See all

K012370Solara JR. Manual WheelchairInvacare Corp. · 2001 · cites it directly6descendants
K063736Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 2007 · cites it directly4descendants
K043332Wheelchair, Model 8500-IICycling and Health Tech. Industry R&D Center · 2004 · 2 generations on2descendants
K181090Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation · 2018 · cites it directly1descendant
K082274Haida Model HD11 Manual WheelchairJiangyin East China Medical Technology Co., Ltd. · 2008 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941989	Action at Manual Wheelchair	Nvacare Corp.	1994	—
0 (this device)	K984447	Model Action at II Manual Wheelchair	Invacare Corp.	1999	—
+1	K012370	Solara JR. Manual Wheelchair	Invacare Corp.	2001	3
+1	K063736	Fuze Mechanical Wheelchair, Models T20 and T50	Pdg Product Design Group, Inc.	2007	1
+2	K043332	Wheelchair, Model 8500-II	Cycling and Health Tech. Industry R&D Center	2004	—
+1	K181090	Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs	Invacare Corporation	2018	—
+2	K082274	Haida Model HD11 Manual Wheelchair	Jiangyin East China Medical Technology Co., Ltd.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0
2007	1	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 K984447, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K952641	Quickie TSR Summary page 1 …echanical 89I0R Predicate Devices The Invacare Model Action AT II substantially equivalent to the Sunrise Medical/Quickie Design Model “Quickie TSR” Manual Wheelchair (K952641 6/9/95) and the Invacare Model Action AT Manual Wheelchair (K941989 6/11/94). Intended Use: The intended use of the Model Action…	Sunrise Medical, Inc.	1995	—
*	K941989	Action at Manual Wheelchair Summary page 1 …substantially equivalent to the Sunrise Medical/Quickie Design Model “Quickie TSR” Manual Wheelchair (K952641 6/9/95) and the Invacare Model Action AT Manual Wheelchair (K941989 6/11/94). Intended Use: The intended use of the Model Action AT II Manual Wheelchair is to provide mobility to persons limited t…	Nvacare Corp.	1994	—

Also cleared against K952641: 3 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K012370	Solara JR. Manual Wheelchair	Invacare Corp.	2001	6
K063736	Fuze Mechanical Wheelchair, Models T20 and T50	Pdg Product Design Group, Inc.	2007	4
K181090	Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs	Invacare Corporation	2018	1
K101719	Tacamo Manual Wheelchair	Dalton Instrument Corp.	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 10, 2012	Class II	Z-0785-2013	Process control	The potential exists for the wheel to rotate freely despite engagement of hub brake.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K012370 (Invacare Corp., 2001) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K952641.

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	—

What is it indicated for?

To provide mobility to persons limited to a sitting postion.

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/K984447 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984447: Model Action at II Manual Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984447

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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