510(k) Report

510(k) · Cleared

Cleared

Bruno Electra-Ride Stair-Way Elevator System

K921648510(k) TraditionalCleared May 4, 199228-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 May 4, 1992 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
May 4, 1992
Review
28 days
Class
Class II
Product code
ILK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 2 descendants cleared1990200020102020
  1. This deviceK921648 Bruno Electra-Ride Stair-Way Elevator SystemBruno Independent Living Aids, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK024345 B.07 Stairway ChairliftServices Industriels Savaria, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK024167 Step-Saver Stairway ChairliftServices Industriels Savaria, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K024345B.07 Stairway ChairliftServices Industriels Savaria, Inc. · 2003 · cites it directly0descendants
  • K024167Step-Saver Stairway ChairliftServices Industriels Savaria, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921648Bruno Electra-Ride Stair-Way Elevator SystemBruno Independent Living Aids, Inc.1992—
+1K024345B.07 Stairway ChairliftServices Industriels Savaria, Inc.2003—
+1K024167Step-Saver Stairway ChairliftServices Industriels Savaria, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
FIG. 1 — Lineage of K921648, 1992–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K024345B.07 Stairway ChairliftServices Industriels Savaria, Inc.20030
K024167Step-Saver Stairway ChairliftServices Industriels Savaria, Inc.20030

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, K024345 (Services Industriels Savaria, Inc., 2003) 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—
Cite this page

510(k) Report. “K921648: Bruno Electra-Ride Stair-Way Elevator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921648

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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