510(k) · Cleared

Cleared

Stealth Products Seating System

K050264510(k) TraditionalCleared Feb 11, 20057-day reviewClass II21 CFR 890.3860

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

Stealth Products · ITI Wheelchair, Powered

Cleared on Feb 11, 2005 as substantially equivalent to K991119 (Invacare Corp., 1999) and 1 other predicate after a 7-day review. Its family tree reaches back 2 generations to 1991.

Decided: Feb 11, 2005
Review: 7 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K911151 (1991). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK911151 Power Wheelchair - Tilt & Recline Seating SystemTarsys Engineering, Inc. · 1991 · Recalled
1 generation backK991119 Tilt/Recliner for Power Wheelchairs, Model 2GInvacare Corp. · 1999 · Recalled
This deviceK050264 Stealth Products Seating SystemStealth Products · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911151	Power Wheelchair - Tilt & Recline Seating System	Tarsys Engineering, Inc.	1991	1
−1	K991119	Tilt/Recliner for Power Wheelchairs, Model 2G	Invacare Corp.	1999	1
0 (this device)	K050264	Stealth Products Seating System	Stealth Products	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	1	0
1997	2	0
1998	1	0
2000	1	0

FIG. 1 — Lineage of K050264, 1991–2005Source: 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 ITI? 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 ITI device

#1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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
*	K991119	Tilt/Recliner for Power Wheelchairs, Model 2G Summary page 1 …Name Wheelchair, Powered Predicate Devices Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804). Stealth Products…	Invacare Corp.	1999	1
*	K992804	T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-TP-320, Ard-TG424, Ard-TS525… Summary page 1 …ons' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804). Stealth Products 510(k) PremarketNotification…	Accelerated Rehab Designs, Inc.	2000	—

Also cleared against K991119: 1 other device →

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?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
2 of the 8 ancestors have a recall of any class.
1 other device also cites its predicate K991119.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITI

29in 2025

2007high 38 (2024) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITI

90in 2025

2007high 278 (2020) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ITI

13so far in 2026, the most since 2007

2007high 13 (2026) · low 0 (2011)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · ITI

647in 2025

2007high 8,741 (2013) · low 123 (2007)2025

MAUDE reports naming product code ITI, 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	18	42	3	123
2008	9	49	3	133
2009	7	63	1	183
2010	6	46	2	157
2011	4	101	0	525
2012	6	155	1	2,919
2013	5	177	0	8,741
2014	5	213	0	7,282
2015	10	174	0	4,685
2016	6	173	1	1,575
2017	4	159	2	301
2018	4	117	0	273
2019	3	244	0	264
2020	6	278	0	205
2021	13	209	3	166
2022	16	96	0	135
2023	8	128	0	223
2024	38	125	1	146
2025	29	90	3 (2)	647
2026	36	108	13	—

What is it indicated for?

The intended function and use of the Stealth Products Powered Seating System for Power Wheelchairs is to provide comfort and pressure relief to power wheelchair users, by providing a method of tilting and reclining the seat and back.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050264: Stealth Products Seating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050264

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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