510(k) Report

510(k) · Cleared

Cleared

Bruno Electra-Ride Elite, Model Sre-2000

K033438510(k) SpecialCleared Nov 20, 200323-day reviewClass II21 CFR 890.5150

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

Bruno Independent Living Aids, Inc. · ILK Transport, Patient, Powered

Cleared on Nov 20, 2003 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Nov 20, 2003
Review
23 days
Class
Class II
Product code
ILK
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared200020052010201520202025
  1. This deviceK033438 Bruno Electra-Ride Elite, Model Sre-2000Bruno Independent Living Aids, Inc. · 2003
  2. Descendant · cites it directly · 0 of its ownK121560 Levant, HomeglideThyssenkrupp Accessibility B.V. · 2012 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K121560Levant, HomeglideThyssenkrupp Accessibility B.V. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033438Bruno Electra-Ride Elite, Model Sre-2000Bruno Independent Living Aids, Inc.2003—
+1K121560Levant, HomeglideThyssenkrupp Accessibility B.V.20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K033438, 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121560Levant, HomeglideThyssenkrupp Accessibility B.V.20120

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, K121560 (Thyssenkrupp Accessibility B.V., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ILK devices

ILK Transport, Patient, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Bruno Electra-RideTMElite Stairway Elevator System, Model SRE-2000, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes; to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K033438: Bruno Electra-Ride Elite, Model Sre-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033438

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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