510(k) Report

510(k) · Cleared

Recalled · 2007

Vangator II

K952946510(k) TraditionalCleared Nov 29, 1995156-day reviewClass II21 CFR 890.3930Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Crow River Industries, Inc. · ING Elevator, Wheelchair, Portable

Cleared on Nov 29, 1995 after a 156-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 3 times.

Decided
Nov 29, 1995
Review
156 days
Class
Class II
Product code
ING
Recalls
3
Predicates
0

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

FIG. 1 — Lineage of K952946Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Recall history across each candidate’s familyin 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 15, 2007Not classifiedZ-2467-2010Device DesignThe wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.
Aug 15, 2007Not classifiedZ-2468-2010Device DesignThe wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.
Aug 15, 2007Not classifiedZ-2469-2010Device DesignThe wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.

No ancestor or descendant has a Class I recall.

How does its category compare?

All ING devices

ING Elevator, Wheelchair, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ING

1in 2012

2008: 12009: 22010: 12011: 12012: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ING

Too few ING 510(k)s in any year since 2007 to give a median.

Recalls per year · ING

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ING

4in 2024

2010: 12012: 12017: 22018: 72019: 42020: 72021: 62022: 32023: 22024: 4
2007high 7 (2018) · low 0 (2007)2025

MAUDE reports naming product code ING, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—30
20081—00
20092—00
20101—01
20111—00
20121—01
20130—00
20140—00
20150—00
20160—00
20170—02
20180—07
20190—04
20200—07
20210—06
20220—03
20230—02
20240—04
20250—00
20260—0—
Cite this page

510(k) Report. “K952946: Vangator II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952946

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026