510(k) · Cleared
ClearedAerolet Toilet Lift, Model Aer-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Economic Holland B.V. · INO Chair, Positioning, Electric
Cleared on Jul 10, 2003 after a 71-day review. The FDA summary names no predicate by number.
- Decided
- Jul 10, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- INO
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 INO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
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.
How does its category compare?
All INO devicesINO Chair, Positioning, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · INO
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · INO
126in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INO
29in 2025
MAUDE reports naming product code INO, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 4 | 126 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 38 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 0 | — | 1 | 29 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Aerolet ToiletLifi “K031045” was developed to assist in patient ability to access bathroom facilities due to medical conditions such as the following:
Multiple Sclerosis
Muscular Dystrophy
Arthritis
Inclusion Body Myositis
Fredricks Ataxia
Parkinsons Syndrome
Post-Polio Syndrome
Fragile elderly
Rehabilitation
Leg fiactures
Hip Replacement
Knee Replacement
Post-Operative Mobility
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031045: Aerolet Toilet Lift, Model Aer-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031045
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026