510(k) · Cleared

Cleared

The Terminator

K922535510(k) TraditionalCleared Jul 24, 199257-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

Top End Wheelchair Sports, Inc. · IOR Wheelchair, Mechanical

Cleared on Jul 24, 1992 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.

Decided: Jul 24, 1992
Review: 57 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 0

13 later devices descend from it, 2 citing it directly.

This deviceK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
Descendant · cites it directly · 12 of its ownK990157 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 · 2 generations on · 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 · 3 generations on · 2 of its ownK220698 Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1999high 2 (2008) · low 0 (2000)2026

Most influential descendants

Showing 5 of 13 · See all

K990157Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999 · cites it directly12descendants
K012167Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001 · cites it directly11descendants
K083231Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009 · 2 generations on4descendants
K051369Syryker Sorano WheelchairStryker Canada · 2005 · 2 generations on4descendants
K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
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 K922535, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K990157	Model Top End Terminator SS Manual Wheelchair	Invacare Corp.	1999	12
K012167	Model Top End Terminator Titanium Manual Wheelchair	Invacare Corp.	2001	11

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?

Of its descendants, K990157 (Invacare Corp., 1999) has gone furthest, with 12 descendants of its own.

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	—

https://510kreport.com/device/K922535 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922535: The Terminator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922535

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026