510(k) · Cleared

Cleared

Model Top End Terminator Titanium Manual Wheelchair

K012167510(k) TraditionalCleared Aug 1, 200120-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 Aug 1, 2001 as substantially equivalent to K922535 (Top End Wheelchair Sports, Inc., 1992) and 1 other predicate after a 20-day review. Its family tree reaches back 2 generations to 1992. 11 later devices descend from it.

Decided: Aug 1, 2001
Review: 20 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K922535 (1992). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
1 generation backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
This deviceK012167 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 · cites it directly · 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 · 2 generations on · 2 of its ownK082970 Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008
Descendant · 3 generations on · 1 of its ownK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all

K083231Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009 · cites it directly4descendants
K051369Syryker Sorano WheelchairStryker Canada · 2005 · cites it directly4descendants
K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023 · 2 generations on2descendants
K082970Marvel Wheelchair, Model EDCAL01Rogue Wheels, Inc. · 2008 · 2 generations on2descendants
K243111Bowhead ERA WheelchairsBowhead Design Corp. · 2025 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922535	The Terminator	Top End Wheelchair Sports, Inc.	1992	—
−1	K990157	Model Top End Terminator SS Manual Wheelchair	Invacare Corp.	1999	—
0 (this device)	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	—
+1	K051369	Syryker Sorano Wheelchair	Stryker Canada	2005	—
+2	K220698	Bambino 3, S3 and S3 Swing, U3 and U3 Light, X	Panthera AB	2023	—
+2	K082970	Marvel Wheelchair, Model EDCAL01	Rogue Wheels, Inc.	2008	—
+3	K243111	Bowhead ERA Wheelchairs	Bowhead Design Corp.	2025	—

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
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 K012167, 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 …heelchair, Mechanical 8910R Predicate Devices The Invacare Top End Terminator Titanium is substantially equivalent to the Model “Top End Terminator” Manual Wheelchair (K922535 7/24/92) and the “Top End Terminator SS Manual Wheelchair” (K990157, 3/4/99). Intended Use: The intended use of the Model Top En…	Top End Wheelchair Sports, Inc.	1992	—
*	K990157	Model Top End Terminator SS Manual Wheelchair Summary page 1 …Terminator Titanium is substantially equivalent to the Model “Top End Terminator” Manual Wheelchair (K922535 7/24/92) and the “Top End Terminator SS Manual Wheelchair” (K990157, 3/4/99). Intended Use: The intended use of the Model Top End Terminator Titanium Manual Wheelchair is to provide mobility to pe…	Invacare Corp.	1999	—

Also cleared against K922535: 1 other device →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K083231	Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT	Panthera Production AB	2009	4
K051369	Syryker Sorano Wheelchair	Stryker Canada	2005	4
K080506	Martin Chair, Model C4S1	Martin Manufacturing Co., LLC	2008	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?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K083231 (Panthera Production AB, 2009) has gone furthest, with 4 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?

The intended use of the Model Top End Terminator Titanium Manual Wheelchair is 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/K012167 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012167: Model Top End Terminator Titanium 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/K012167

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026