510(k) · Cleared
ClearedWheeled Stretcher
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · FPO Stretcher, Wheeled
Cleared on Jun 3, 1996 after a 49-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 3, 1996
- Review
- 49 days
- Class
- Class II
- Product code
- FPO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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 FPO? 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 |
|---|---|---|---|
| * | — | Stryker "Synergy Series" Stretchers Named without a submission 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 FPO devicesFPO Stretcher, Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPO
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FPO
Too few FPO 510(k)s in any year since 2007 to give a median.
Recalls per year · FPO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPO
897in 2025
MAUDE reports naming product code FPO, 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 | — | 6 | 117 |
| 2008 | 1 | — | 3 | 385 |
| 2009 | 0 | — | 12 | 2,337 |
| 2010 | 0 | — | 1 | 4,049 |
| 2011 | 1 | — | 6 | 5,891 |
| 2012 | 0 | — | 1 | 6,334 |
| 2013 | 0 | — | 0 | 5,743 |
| 2014 | 0 | — | 1 | 1,633 |
| 2015 | 0 | — | 0 | 381 |
| 2016 | 0 | — | 1 | 205 |
| 2017 | 0 | — | 0 | 230 |
| 2018 | 0 | — | 0 | 573 |
| 2019 | 0 | — | 0 | 663 |
| 2020 | 0 | — | 0 | 694 |
| 2021 | 0 | — | 0 | 874 |
| 2022 | 0 | — | 2 | 694 |
| 2023 | 0 | — | 0 | 1,028 |
| 2024 | 0 | — | 0 | 956 |
| 2025 | 0 | — | 1 | 897 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The subject stretcher and predicate are intended to be used with the general population to transport patients and to allow for patient care before, during, and after transport. The stretchers may be used in or for various patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home care. When fitted with the optional radiolucent surface, the stretcher may be used for acquisition of radiographic images.
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/K961437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961437: 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/K961437
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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