510(k) · Cleared
Recalled · 2011Stryker Powered Wheeled Stretcher
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · INK Stretcher, Wheeled, Powered
Cleared on Nov 8, 2002 as substantially equivalent to K942948 (Stryker Corp., 1995) after a 115-day review. Its family tree reaches back 1 generation to 1995. 20 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 8, 2002
- Review
- 115 days
- Class
- Class II
- Product code
- INK
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942948 (1995). 20 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK942948 Stryker Powered StretcherStryker Corp. · 1995
- This deviceK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002
- Descendant · cites it directly · 11 of its ownK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- Descendant · 2 generations on · 9 of its ownK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 7 of its ownK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K090136Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · cites it directly11descendants
- K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection…Ortho Kinematics, Inc. · 2011 · 2 generations on10descendants
- K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc. · 2013 · 2 generations on9descendants
- K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc. · 2014 · 3 generations on8descendants
- K172327VMA™ System version 3.0Ortho Kinematics, Inc. · 2017 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| 0 (this device) | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | — |
| +1 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| +2 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| +2 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| +3 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| +4 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K942948 | Stryker Powered Stretcher Our OCR of the scanned summary read K942548, FDA’s number for Jennings Javelin (Jfi Endineering, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker Powered Wheel Stretcher”. | 1995 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2011 | Not classified | Z-2926-2011 | Nonconforming Material/Component | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely… |
| Mar 19, 2010 | Not classified | Z-2185-2010 | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. |
| Mar 19, 2010 | Not classified | Z-2187-2010 | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. |
| Mar 19, 2010 | Not classified | Z-2186-2010 | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. |
| Mar 19, 2010 | Not classified | Z-2183-2010 | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. |
| Mar 19, 2010 | Not classified | Z-2184-2010 | Component design/selection | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All INK devicesINK Stretcher, Wheeled, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Stryker Powered Wheeled Stretcher is an
electromechanical stretcher that provides a method of
transporting patients within healthcare facilities. The
stretcher may be used for minor procedures and
short-term stay, typical of existing stretcher
applications.
The drive-assist Big Wheel provides the healthcare
caregiver greater maneuverability in steering and
moving the stretcher with significantly less force.
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/K022309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022309: Stryker Powered Wheeled Stretcher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022309
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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