510(k) · Cleared
Recalled · Class II · 2018Power-Load Cot Fastener System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Medical · FPO Stretcher, Wheeled
Cleared on Dec 20, 2011 as substantially equivalent to K072598 (International Retail Services Group, LLC, 2008) after a 15-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 3 times.
- Decided
- Dec 20, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- FPO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942948 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 2 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 1 generation backK072598 Irsg I-Mover for BedsInternational Retail Services Group, LLC · 2008
- This deviceK113598 Power-Load Cot Fastener SystemStryker Medical · 2011
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 | K072598 | Irsg I-Mover for Beds | International Retail Services Group, LLC | 2008 | — |
| 0 (this device) | K113598 | Power-Load Cot Fastener System | Stryker Medical | 2011 | — |
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 |
|---|---|---|---|
| * | K072598 | Irsg I-Mover for BedsSummary page 1…General Hospital Classification: Class 11 Predicate Device: IRSG I-Mover for Beds, International Retail Services Group LLC (K072598) Device Description The Power-LOAD system secures an ambulance cot within an emergency transport vehicle… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2018 | Class II | Z-1350-2019 | Under Investigation by firm | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. |
| Mar 12, 2018 | Class II | Z-1389-2018 | Nonconforming Material/Component | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. |
| Oct 11, 2012 | Class II | Z-0566-2013 | Component design/selection | Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted. |
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 5.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FPO devicesFPO Stretcher, Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Power-LOADTm cot fastening system (model 6390) is intended to assist wit loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 Ibs, which includes the weight of the ambulance cot, patient, and equipment attached to the cot (i.e. oxygen bottles, monitors, and/or pumps). The intended users of the device will be trained professionals including: emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers. The expected service life of the product is 7 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113598: Power-Load Cot Fastener System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113598
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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