510(k) · Cleared

Cleared

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

K162621510(k) TraditionalCleared Apr 17, 2017209-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

Invacare Corporation · IOR Wheelchair, Mechanical

Cleared on Apr 17, 2017 as substantially equivalent to K935398 (Invacare Corp., 1994) after a 209-day review. Its family tree reaches back 1 generation to 1994. 22 later devices descend from it.

Decided: Apr 17, 2017
Review: 209 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935398 (1994). 22 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
This deviceK162621 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy…Invacare Corporation · 2017
Descendant · cites it directly · 21 of its ownK181795 AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018
Descendant · 2 generations on · 12 of its ownK201461 Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021
Descendant · 3 generations on · 3 of its ownK232198 Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
Descendant · 2 generations on · 3 of its ownK231750 MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. · 2023
Descendant · 3 generations on · 2 of its ownK232230 YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2018high 9 (2026) · low 0 (2020)2026

Most influential descendants

Showing 5 of 22 · See all

K181795AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018 · cites it directly21descendants
K201461Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021 · 2 generations on12descendants
K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023 · 3 generations on3descendants
K231750MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. · 2023 · 2 generations on3descendants
K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935398	Tracer Series Manual Wheelchairs	Invacare Corp.	1994	—
0 (this device)	K162621	Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra…	Invacare Corporation	2017	—
+1	K181795	AST Model MA012 and MS019 Rehab Wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2018	—
+2	K201461	Manual Wheelchair, Model A011	Ningbo Shenyu Medical Equipment Co.,Ltd	2021	—
+3	K232198	Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—
+2	K231750	MA012 Aluminum wheelchair, MS019 steel wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2023	—
+3	K232230	YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	1	0
2021	1	0
2022	1	0
2023	5	0
2024	2	0
2025	2	0
2026	9	0

FIG. 1 — Lineage of K162621, 1994–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K935398	Tracer Series Manual Wheelchairs Summary page 4 …Product Code: IOR: Wheelchair, Mechanical Regulation Description: Mechanical Wheelchair PREDICATE DEVICE: Tracer Series Mechanical Wheelchairs (K935398) REFERENCE DEVICE: Ride Lite 9000 Series Wheelchair (K881951) DEVICE DESCRIPTION The Invacare® Tracer®…	Invacare Corp.	1994	—
†	K881951	Ride-Lite 9000 Series Wheelchair	Invacare Corp.	1988	—

Also cleared against K935398: 11 other devices →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181795	AST Model MA012 and MS019 Rehab Wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2018	21

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?

Its one ancestor has no recall.
Of its descendants, K181795 (Sichuan Ast Medical Equipment Co., Ltd., 2018) has gone furthest, with 21 descendants of its own.
11 other devices also cite its predicate K935398.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

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?

The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162621: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162621

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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