510(k) · Cleared
ClearedWinco Model S550 Stretchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winco Manufacturing, LLC · INK Stretcher, Wheeled, Powered
Cleared on Apr 11, 2016 as substantially equivalent to K110671 (Winco Mfg., LLC, 2011) after a 262-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Apr 11, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- INK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942948 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 3 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 2 generations backK091043 Power Drive Chair, Model: TMM6Transmotion Medical, Inc. · 2009
- 1 generation backK110671 Winco StretchairWinco Mfg., LLC · 2011
- This deviceK152056 Winco Model S550 StretchairWinco Manufacturing, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −3 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −2 | K091043 | Power Drive Chair, Model: TMM6 | Transmotion Medical, Inc. | 2009 | — |
| −1 | K110671 | Winco Stretchair | Winco Mfg., LLC | 2011 | — |
| 0 (this device) | K152056 | Winco Model S550 Stretchair | Winco Manufacturing, LLC | 2016 | — |
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 INK? 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? (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 |
|---|---|---|---|
| * | K110671 | Winco StretchairSummary page 4…Usual Name: Stretcher Classification Name: Powered, Wheeled Siretcher (890.3690) Regulatory Class: Il Product Code: INK PREDICATE DEVICE Winco Stretchair Model S999 (K110671) DEVICE DESCRIPTION The Winco Model S550 Stretchair is a battery powered device designed for use in healthcare facilities. Its’… | 2011 |
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All INK devicesINK Stretcher, Wheeled, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · INK
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · INK
Too few INK 510(k)s in any year since 2007 to give a median.
Recalls per year · INK
7in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INK
101in 2025
MAUDE reports naming product code INK, 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 | 13 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 5 | 529 |
| 2011 | 2 | — | 7 | 1,529 |
| 2012 | 0 | — | 0 | 625 |
| 2013 | 0 | — | 0 | 438 |
| 2014 | 1 | — | 0 | 88 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 79 |
| 2020 | 0 | — | 0 | 89 |
| 2021 | 0 | — | 0 | 114 |
| 2022 | 0 | — | 0 | 93 |
| 2023 | 0 | — | 0 | 147 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 101 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152056: Winco Model S550 Stretchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152056
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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