510(k) · Cleared

Cleared

Litestream 500E

K042444510(k) TraditionalCleared Oct 21, 200442-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

Pride Mobility Products Corp. · IOR Wheelchair, Mechanical

Cleared on Oct 21, 2004 as substantially equivalent to K850536 (Motion Designs, Inc., 1985) after a 42-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Oct 21, 2004
Review: 42 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K850536 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK850536 Quickie WheelchairsMotion Designs, Inc. · 1985
This deviceK042444 Litestream 500EPride Mobility Products Corp. · 2004
Descendant · cites it directly · 0 of its ownK111739 Kids Rock 3 ChairPride Mobility Products Corp. · 2011

Most influential descendants

Showing 1 of 1 · See all

K111739Kids Rock 3 ChairPride Mobility Products Corp. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850536	Quickie Wheelchairs	Motion Designs, Inc.	1985	—
0 (this device)	K042444	Litestream 500E	Pride Mobility Products Corp.	2004	—
+1	K111739	Kids Rock 3 Chair	Pride Mobility Products Corp.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K042444, 1985–2011Source: 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
*	K850536	Quickie Wheelchairs Summary page 4 …ode: IOR Comparison to Predicate Devices: The Litestream 500E Mechanical Wheelchair is substantially equivalent to the Sunrise Medical Quickie (K850536) Device Description: The Litestream 500E mechanical wheelchair is lightweight and designed to provide mobilit…	Motion Designs, Inc.	1985	—

Also cleared against K850536: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K111739	Kids Rock 3 Chair	Pride Mobility Products Corp.	2011	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?

Its one ancestor has no recall.
Of its descendants, K111739 (Pride Mobility Products Corp., 2011) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K850536.

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 intended use of the Litestream 500E is to provide mobility to persons limited to a seated position that are capable of operating a mechanical wheelchair.

The Litestream 500E mechanical wheelchair enhances the mobility of users whom are partially or fully non-ambulatory.

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/K042444 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042444: Litestream 500E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042444

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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