510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Levant, Homeglide

K121560510(k) TraditionalCleared Nov 1, 2012156-day reviewClass II21 CFR 890.5150Recalls 1

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

Thyssenkrupp Accessibility B.V. · ILK Transport, Patient, Powered

Cleared on Nov 1, 2012 as substantially equivalent to K113308 (Bruno Independent Living Aids, Inc., 2012) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 2003. It has been recalled once.

Decided
Nov 1, 2012
Review
156 days
Class
Class II
Product code
ILK
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K033438 (2003). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestorK033438 · Bruno Electra-Ride Elite, Model Sre-2000 · Bruno Independent Living Aids, Inc. · 200320002002200420062008201020122014
Other ancestors, by generation 1 generation back: 1 other ancestor K033438 · Bruno Electra-Ride Elite, Model Sre-2000 · Bruno Independent Living Aids, Inc. · 20030
  1. Root · 1 generation backK033438 Bruno Electra-Ride Elite, Model Sre-2000Bruno Independent Living Aids, Inc. · 2003
  2. This deviceK121560 Levant, HomeglideThyssenkrupp Accessibility B.V. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K033438Bruno Electra-Ride Elite, Model Sre-2000Bruno Independent Living Aids, Inc.2003—
0 (this device)K121560Levant, HomeglideThyssenkrupp Accessibility B.V.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K121560, 2003–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 ILK? 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 ILK device

  1. #1 K222818 Xpedition ™ Powered Stair Chair (625700000000)score 5.3 · 3 generations · no Class I recall
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K113308Bruno Elan Stairway ElevatorBruno Independent Living Aids, Inc.2012—
*K033438Bruno Electra-Ride Elite, Model Sre-2000
Summary page 1
…ILK Submission K121560 Predicate Devices: Stair Lift BRUNO Independent Living Aids INC KI 13308, K(033438 CFR 890.5150 Promotional Product Description Levant/ HomeGlide is a stair lift for transport of…
Bruno Independent Living Aids, Inc.2003—

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 6, 2012Class IIZ-0557-2013Device DesignThe seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.

How does its category compare?

All ILK devices

ILK Transport, Patient, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ILK

1in 2024

2008: 12009: 12010: 22011: 12012: 32014: 12023: 12024: 1
2007high 3 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILK

150in 2012

2012: 150 days median
2007high 150 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ILK

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · ILK

32in 2025

2007: 12008: 42010: 12011: 12012: 42013: 42014: 22015: 22023: 52024: 182025: 32
2007high 32 (2025) · low 0 (2009)2025

MAUDE reports naming product code ILK, 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—01
20081—04
20091—00
20102—01
20111—01
2012315014
20130—04
20141—02
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—05
20241—018
20250—032
20260—0—

What is it indicated for?

ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to

mechanically transport one mobility impaired person in a fold-dawn seat, up and

down straight stairs, indoors and outdoors.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K121560: Levant, Homeglide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121560

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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