510(k) · Cleared
ClearedFLOW2, Swing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thyssenkrupp Accessibility B.V. · ILK Transport, Patient, Powered
Cleared on Oct 26, 2012 as substantially equivalent to K970927 (Bruno Independent Living Aids, Inc., 1997) after a 150-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 26, 2012
- Review
- 150 days
- Class
- Class II
- Product code
- ILK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970927 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970927 Bruno Electra-Ride Iii Stairway Elevator SystemBruno Independent Living Aids, Inc. · 1997
- This deviceK121561 FLOW2, SwingThyssenkrupp Accessibility B.V. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970927 | Bruno Electra-Ride Iii Stairway Elevator System | Bruno Independent Living Aids, Inc. | 1997 | — |
| 0 (this device) | K121561 | FLOW2, Swing | Thyssenkrupp Accessibility B.V. | 2012 | — |
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 |
|---|---|---|---|
| * | K970927 | Bruno Electra-Ride Iii Stairway Elevator SystemSummary page 1…ode: ILK Submission K121561 Predicate Device: Stair Lift BRUNO Independent Living Aids INC K970927 CFR 890.5150 Promotional Product Description Flow2 mono rail chairlift brings one person safely… | 1997 |
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 K970927.
How does its category compare?
All ILK devicesILK 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
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?
ThyssenKrup .p Accessibility's Battery Operated Stair Lift FLOW2 is intended to
mechanically transport one mobility impaired person in a fold-down seat, up and
down curved stairs, indoors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121561: FLOW2, Swing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121561
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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