510(k) · Cleared

Cleared

Millennium Series Manual Wheelchairs

K024030510(k) TraditionalCleared Dec 12, 20026-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

Evermed Corp. · IOR Wheelchair, Mechanical

Cleared on Dec 12, 2002 as substantially equivalent to K935398 (Invacare Corp., 1994) after a 6-day review. Its family tree reaches back 1 generation to 1994.

Decided: Dec 12, 2002
Review: 6 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935398 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
This deviceK024030 Millennium Series Manual WheelchairsEvermed Corp. · 2002

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)	K024030	Millennium Series Manual Wheelchairs	Evermed Corp.	2002	—

FIG. 1 — Lineage of K024030, 1994–2002Source: 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 1 …Wheelchair, mechanical Predicate device: Tracer Series Mechanical Wheelchairs manufactured by Invacare Corp. (K935398) Intend use of device: The Millennium Series Mechanical Wheelchair provides enhanced mobility to physically challenged pe…	Invacare Corp.	1994	—

Also cleared against K935398: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
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.

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 Millennium Series Mechanical Wheelchair provides enhanced

mobility to physically challenged persons limited to a sitting

position

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024030 · printed Nov 4, 2026

Cite this page

510(k) Report. “K024030: Millennium Series Manual Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024030

Report an extraction error

Are you the manufacturer?

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