510(k) · Cleared

Cleared

Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,

K032402510(k) TraditionalCleared Sep 24, 200351-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

Convaid Products, Inc. · IOR Wheelchair, Mechanical

Cleared on Sep 24, 2003 as substantially equivalent to K952641 (Sunrise Medical, Inc., 1995) after a 51-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Sep 24, 2003
Review: 51 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952641 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK952641 Quickie TSRSunrise Medical, Inc. · 1995
This deviceK032402 Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T…Convaid Products, Inc. · 2003
Descendant · cites it directly · 0 of its ownK063521 Nissin Pediatric Series WheelchairNissin Medical, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K063521Nissin Pediatric Series WheelchairNissin Medical, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K952641	Quickie TSR	Sunrise Medical, Inc.	1995	—
0 (this device)	K032402	Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,	Convaid Products, Inc.	2003	—
+1	K063521	Nissin Pediatric Series Wheelchair	Nissin Medical, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K032402, 1995–2007Source: 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
*	K952641	Quickie TSR Summary page 1 …Legally Marketed Devices 1. Manufacture Name: Sunrise Medical 2. Name: Quickie TSR 3. K Number: K95264 1 4. Date Cleared: 07/06/1995 I. Manufacture Name: Sunrise Medical 2. Name:…	Sunrise Medical, Inc.	1995	—
†	K973673	Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series	Sunrise Medical, Inc.	1997	4

Also cleared against K952641: 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
K063521	Nissin Pediatric Series Wheelchair	Nissin Medical, Inc.	2007	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, K063521 (Nissin Medical, Inc., 2007) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K952641.

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?

Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support…

Read the full statement (161 words)

This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions:

- Amputee;

- Arthritis;

- Arthrogriposis;

- Cerebral Palsy;

- Geriatric conditions;

- Head injury or trauma;

- Hemiplegics;

- Multiple Sclerosis;

- Muscular Dystrophy;

- Paraplegic;

- Polio;

- Quadriplegic;

- Spina Bifida;

- StokeJCVA;

- Tetraplegic; and

- Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032402 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032402: Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032402

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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