510(k) · Cleared

Cleared

Ki Power Tilt System

K201869510(k) TraditionalCleared Sep 5, 20231,155-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

Ki Mobility, LLC · ITI Wheelchair, Powered

Cleared on Sep 5, 2023 as substantially equivalent to K972564 (Mechanical Application Designs, Inc., 1997) after a 1,155-day review. Its family tree reaches back 1 generation to 1997.

Decided: Sep 5, 2023
Review: 1,155 days
Class: Class II
Product code: ITI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972564 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK972564 Tilt Master CG System (Center of Gravity), Tilt-N-Space-SeatMechanical Application Designs, Inc. · 1997
This deviceK201869 Ki Power Tilt SystemKi Mobility, LLC · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972564	Tilt Master CG System (Center of Gravity), Tilt-N-Space-Seat	Mechanical Application Designs, Inc.	1997	—
0 (this device)	K201869	Ki Power Tilt System	Ki Mobility, LLC	2023	—

FIG. 1 — Lineage of K201869, 1997–2023Source: 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? (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
*	K972564	Tilt Master CG System (Center of Gravity), Tilt-N-Space-Seat Summary page 4 …ITI Equivalence Claimed to Predicate Device The Ki Mobility Power Tilt System is equivalent to the TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT (K972564), manufactured by MECHANICAL APPLICATION DESIGNS. Description of the Ki Power Tilt System The Ki Power Tilt Syst…	Mechanical Application Designs, Inc.	1997	—

Also cleared against K972564: 2 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.
2 other devices also cite its predicate K972564.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

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 Ki Mobility Power Tilt System kit design is intended for use on a manual wheelchair to provide patients with

posterior tilt for positioning and seating pressure relief.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201869 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201869: Ki Power Tilt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201869

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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