510(k) · Cleared
ClearedPinnacle Stair Way Lift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Harmar, LLC · ILK Transport, Patient, Powered
Cleared on Jul 1, 2009 as substantially equivalent to K033752 (Bruno Independent Living Aids, Inc., 2003) after an 8-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jul 1, 2009
- Review
- 8 days
- Class
- Class II
- Product code
- ILK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033752 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK033752 Bruno Electra-Ride Stairway Elevator System. Model Sre-1540Bruno Independent Living Aids, Inc. · 2003
- This deviceK091858 Pinnacle Stair Way LiftSummit Harmar, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033752 | Bruno Electra-Ride Stairway Elevator System. Model Sre-1540 | Bruno Independent Living Aids, Inc. | 2003 | — |
| 0 (this device) | K091858 | Pinnacle Stair Way Lift | Summit Harmar, LLC | 2009 | — |
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 K222818 Xpedition ™ Powered Stair Chair (625700000000)score 5.3 · 3 generations · no Class I recall
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K033752 | Bruno Electra-Ride Stairway Elevator System. Model Sre-1540 | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K033752.
How does its category compare?
All ILK devicesILK Transport, Patient, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ILK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ILK
150in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILK
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILK
32in 2025
MAUDE reports naming product code ILK, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 150 | 1 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Pinnacle Stair Way Lift is to assist transfers of
patients or mobility impaired persons up and down flights of stairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091858: Pinnacle Stair Way Lift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091858
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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