510(k) · Cleared
ClearedSupertilt Plus (STP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Power Plus Mobility · IOR Wheelchair, Mechanical
Cleared on Oct 28, 2022 as substantially equivalent to K951138 (Invacare Corp., 1995) after a 164-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 28, 2022
- Review
- 164 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951138 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951138 Models Phoenix and Concept 45 Manual Mechanical WheelchairsInvacare Corp. · 1995
- This deviceK221435 Supertilt Plus (STP)Power Plus Mobility · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951138 | Models Phoenix and Concept 45 Manual Mechanical Wheelchairs | Invacare Corp. | 1995 | — |
| 0 (this device) | K221435 | Supertilt Plus (STP) | Power Plus Mobility | 2022 | — |
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 IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K951138 | Models Phoenix and Concept 45 Manual Mechanical WheelchairsSummary page 4…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K951138 11 Concept 45 11 ioR Device Descrip… | 1995 |
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 K951138.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
The intended use for the manual (mechanical) wheelchair is to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. All other uses are prohibited.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221435: Supertilt Plus (STP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221435
Report an extraction error
Are you the manufacturer?
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