510(k) · Cleared
ClearedWinco Stretchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winco Mfg., LLC · INK Stretcher, Wheeled, Powered
Cleared on Apr 22, 2011 as substantially equivalent to K091043 (Transmotion Medical, Inc., 2009) after a 44-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Apr 22, 2011
- Review
- 44 days
- Class
- Class II
- Product code
- INK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942948 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 2 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 1 generation backK091043 Power Drive Chair, Model: TMM6Transmotion Medical, Inc. · 2009
- This deviceK110671 Winco StretchairWinco Mfg., LLC · 2011
- Descendant · cites it directly · 0 of its ownK152056 Winco Model S550 StretchairWinco Manufacturing, LLC · 2016
Most influential descendants
Showing 1 of 1 · See all- K152056Winco Model S550 StretchairWinco Manufacturing, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −2 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −1 | K091043 | Power Drive Chair, Model: TMM6 | Transmotion Medical, Inc. | 2009 | — |
| 0 (this device) | K110671 | Winco Stretchair | Winco Mfg., LLC | 2011 | — |
| +1 | K152056 | Winco Model S550 Stretchair | Winco Manufacturing, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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 |
|---|---|---|---|
| * | K091043 | Power Drive Chair, Model: TMM6Summary page 1…orida 34474 Common or Usual Name Stretcher Classification Name Stretcher, Wheeled, Powered Predicate Device TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043) Intended Use The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facili… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152056 | Winco Model S550 Stretchair | 2016 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K152056 (Winco Manufacturing, LLC, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All INK devicesINK Stretcher, Wheeled, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Stretchair is to provide a method of transporting patients within healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110671: Winco Stretchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110671
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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