510(k) · Cleared

Cleared

Model Top End Terminator SS Manual Wheelchair

K990157510(k) TraditionalCleared Feb 3, 199915-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

Invacare Corp. · IOR Wheelchair, Mechanical

Cleared on Feb 3, 1999 as substantially equivalent to K922535 (Top End Wheelchair Sports, Inc., 1992) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1992. 12 later devices descend from it.

Decided: Feb 3, 1999
Review: 15 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K922535 (1992). 2 ancestors in all. 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
This deviceK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
Descendant · cites it directly · 11 of its ownK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
Descendant · cites it directly · 4 of its ownK083231 Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009
Descendant · 2 generations on · 4 of its ownK051369 Syryker Sorano WheelchairStryker Canada · 2005
Descendant · 2 generations on · 2 of its ownK220698 Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023
Descendant · 3 generations on · 2 of its ownK082970 Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2001high 2 (2008) · low 0 (2002)2026

Most influential descendants

Showing 5 of 12 · See all

K012167Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001 · cites it directly11descendants
K083231Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009 · cites it directly4descendants
K051369Syryker Sorano WheelchairStryker Canada · 2005 · 2 generations on4descendants
K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023 · 2 generations on2descendants
K082970Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922535	The Terminator	Top End Wheelchair Sports, Inc.	1992	—
0 (this device)	K990157	Model Top End Terminator SS Manual Wheelchair	Invacare Corp.	1999	—
+1	K012167	Model Top End Terminator Titanium Manual Wheelchair	Invacare Corp.	2001	—
+1	K083231	Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT	Panthera Production AB	2009	—
+2	K051369	Syryker Sorano Wheelchair	Stryker Canada	2005	—
+2	K220698	Bambino 3, S3 and S3 Swing, U3 and U3 Light, X	Panthera AB	2023	—
+3	K082970	Marvel Wheelchair, Model EDCAL01	Rogue Wheels, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	1	0
2008	2	0
2009	2	0
2011	1	0
2013	1	0
2014	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K990157, 1992–2026Source: 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? (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
*	K922535	The Terminator Summary page 1 …ion Name: Wheelchair, Mechanical 8910R Predicate Devices Invacare Top End Terminator SS is substantially equivalent to the Model “Top End Terminator” Manual Wheelchair (K922535 7/24/92) and the Quickie Designs Model “Quickie Suspension Wheelchair Series Model XTR” Manual Wheelchairs (K982989 10/5/98). In…	Top End Wheelchair Sports, Inc.	1992	—
*	K982989	Quickie Suspension Wheelchair Series Model XTR Summary page 1 …to the Model “Top End Terminator” Manual Wheelchair (K922535 7/24/92) and the Quickie Designs Model “Quickie Suspension Wheelchair Series Model XTR” Manual Wheelchairs (K982989 10/5/98). Intended Use: The intended use of the Model Top End Terminator SS Manual Wheelchair is to provide mobility to persons…	Sunrise Medical, Inc.	1998	—

Also cleared against K922535: 1 other device →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012167	Model Top End Terminator Titanium Manual Wheelchair	Invacare Corp.	2001	11
K083231	Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT	Panthera Production AB	2009	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 2 ancestors has a recall.
Of its descendants, K012167 (Invacare Corp., 2001) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K922535.

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?

To provide mobility to persons limited to a sitting position.

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/K990157 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990157: Model Top End Terminator SS 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/K990157

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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