510(k) · Cleared
ClearedProcedural Strecher with Intellidrive P8000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Co. · INK Stretcher, Wheeled, Powered
Cleared on Sep 19, 2011 as substantially equivalent to K022309 (Stryker Corp., 2002) after a 20-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 19, 2011
- Review
- 20 days
- Class
- Class II
- Product code
- INK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942948 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K022309 | Stryker Powered Wheeled StretcherSummary page 1…Classification Name: Stretcher, Wheeled, Powered, (21 CFR 890.3690, Product Code INK) Regulatory Class: Class 11 Predicate Devices: Stryker Powered Wheeled Stretcher, #K022309 Device Description: The Hill-Rom Procedural Stretcher product is a movable, caster- mounted stretcher. The product has side rail… | 2002 |
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 16 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate K022309.
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 Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The IntellidriveTM Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
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/K112502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112502: Procedural Strecher with Intellidrive P8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112502
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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