510(k) · Cleared

Cleared

AST Model MA012 and MS019 Rehab Wheelchair

K181795510(k) TraditionalCleared Sep 25, 201882-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

Sichuan Ast Medical Equipment Co., Ltd. · IOR Wheelchair, Mechanical

Cleared on Sep 25, 2018 as substantially equivalent to K162621 (Invacare Corporation, 2017) after an 82-day review. Its family tree reaches back 2 generations to 1994. 21 later devices descend from it.

Decided: Sep 25, 2018
Review: 82 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K935398 (1994). 21 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 2 generations backK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
1 generation backK162621 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy…Invacare Corporation · 2017
This deviceK181795 AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018
Descendant · cites it directly · 12 of its ownK201461 Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021
Descendant · 2 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 · cites it directly · 3 of its ownK231750 MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. · 2023
Descendant · 2 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
Descendant · 2 generations on · 1 of its ownK232199 Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2019high 9 (2026) · low 0 (2020)2026

Most influential descendants

Showing 5 of 21 · See all

K201461Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021 · cites it directly12descendants
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 · 2 generations on3descendants
K231750MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. · 2023 · cites it directly3descendants
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 · 2 generations on2descendants
K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935398	Tracer Series Manual Wheelchairs	Invacare Corp.	1994	—
−1	K162621	Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra…	Invacare Corporation	2017	—
0 (this device)	K181795	AST Model MA012 and MS019 Rehab Wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2018	—
+1	K201461	Manual Wheelchair, Model A011	Ningbo Shenyu Medical Equipment Co.,Ltd	2021	—
+2	K232198	Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—
+1	K231750	MA012 Aluminum wheelchair, MS019 steel wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2023	—
+2	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	—
+2	K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K181795, 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

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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
*	K162621	Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual… Summary page 5 …antial Equivalence of the AST Model MA012 and MS019 Rehab Wheelchair, with the predicate Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621). MA012 and MS019 have the same intended uses and similar indications, technological characteristics and principles of operation…	Invacare Corporation	2017	—

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K201461	Manual Wheelchair, Model A011	Ningbo Shenyu Medical Equipment Co.,Ltd	2021	12
K231750	MA012 Aluminum wheelchair, MS019 steel wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2023	3
K253632	Manual Wheelchair (W50)	Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd.	2026	0
K252825	Manual Wheelchair (W45)	Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd.	2025	0
K213790	Aluminum back folding wheelchair SYIV 100-LQXAL2482-407	Mobility Source Medical Technology Co., Ltd.	2022	0
K190534	Manual Wheelchair SIVFH2A102	Jiangsu Horizon Medical Science & Technology Co., Ltd.	2019	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?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 23.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K201461 (Ningbo Shenyu Medical Equipment Co.,Ltd, 2021) has gone furthest, with 12 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. 2018, 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 AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181795 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181795: AST Model MA012 and MS019 Rehab Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181795

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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