510(k) · Cleared

Cleared

Manual Wheelchair

K982607510(k) TraditionalCleared Aug 31, 199835-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

G. Hirsch and Co., Inc. · IOR Wheelchair, Mechanical

Cleared on Aug 31, 1998 as substantially equivalent to K935398 (Invacare Corp., 1994) and 2 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.

Decided: Aug 31, 1998
Review: 35 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K915262 (1992). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK915262 Bantex Brand WheelchairsBantex Corp. · 1992
This deviceK982607 Manual WheelchairG. Hirsch and Co., Inc. · 1998
Descendant · cites it directly · 4 of its ownK031910 Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003
Descendant · 2 generations on · 2 of its ownK051709 Hippocampe WheelchairVipamat Technologie · 2005
Descendant · 3 generations on · 0 of its ownK251570 Hippocampe Marathon and TrailVipamat Sarl · 2025
Descendant · 2 generations on · 0 of its ownK120302 Mechanical WheelchairNovaf Andalucia 2007, SL · 2012
Descendant · 2 generations on · 0 of its ownK101217 Mac-Mobile Aquatic ChairRehamed Intl., LLC · 2010

Most influential descendants

Showing 5 of 5 · See all

K031910Stainless Steel Aquatic WheelchairDb Perks & Associates, Ltd. · 2003 · cites it directly4descendants
K051709Hippocampe WheelchairVipamat Technologie · 2005 · 2 generations on2descendants
K251570Hippocampe Marathon and TrailVipamat Sarl · 2025 · 3 generations on0descendants
K120302Mechanical WheelchairNovaf Andalucia 2007, SL · 2012 · 2 generations on0descendants
K101217Mac-Mobile Aquatic ChairRehamed Intl., LLC · 2010 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915262	Bantex Brand Wheelchairs	Bantex Corp.	1992	—
0 (this device)	K982607	Manual Wheelchair	G. Hirsch and Co., Inc.	1998	—
+1	K031910	Stainless Steel Aquatic Wheelchair	Db Perks & Associates, Ltd.	2003	—
+2	K051709	Hippocampe Wheelchair	Vipamat Technologie	2005	—
+3	K251570	Hippocampe Marathon and Trail	Vipamat Sarl	2025	—
+2	K120302	Mechanical Wheelchair	Novaf Andalucia 2007, SL	2012	—
+2	K101217	Mac-Mobile Aquatic Chair	Rehamed Intl., LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2010	1	0
2012	1	0
2025	1	0

FIG. 1 — Lineage of K982607, 1992–2025Source: 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K854175	FDA’s K854175 is Defigard 2000 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Odam	1986	—
*	K935398	Tracer Series Manual Wheelchairs Summary page 1 …ibits no material differences from the predicate devices listed in number (3) above. Please see the enclosed catalog pages of Invacare Tracer Series wheelchairs (510(k) #K935398) for a comparison of design features, which we believe to be equivalent to our submitted wheelchair. Some items for comparison ar…	Invacare Corp.	1994	—
*	K915262	Bantex Brand Wheelchairs Summary page 1 …uivalence, together with their 510(k) numbers are as follows: Mechanical Wheelchair 980.3850, KS45175 Tracer Series Manual Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262 Universal Wheelchair, K930411 (4) The device consists of a folding chromed steel frame with cross braces, slung fabric seat and…	Bantex Corp.	1992	—
*	K930411	Universal Wheelchair Summary page 1 …510(k) numbers are as follows: Mechanical Wheelchair 980.3850, KS45175 Tracer Series Manual Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262 Universal Wheelchair, K930411 (4) The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armre…	Everest & Jennings, Inc.	1993	—

Also cleared against K935398: 11 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K031910	Stainless Steel Aquatic Wheelchair	Db Perks & Associates, Ltd.	2003	4

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?

None of the 3 ancestors has a recall.
Of its descendants, K031910 (Db Perks & Associates, Ltd., 2003) has gone furthest, with 4 descendants of its own.
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?

For transportation of disabled persons.

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/K982607 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982607: Manual Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982607

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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