# K140095: Prime Zoom Stretcher

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: May 20, 2014 after 126 days
- Product code: INK (Stretcher, Wheeled, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942948 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022309: Stryker Powered Wheeled Stretcher, Stryker Corp. (2002) Summary page 1.

## Recalls of this device
- Feb 5, 2016 · Class II · Z-1184-2016: The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additiv

## Indications for use
The Prime Series® Stretcher with Zoom® Motorized Drive 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, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

Source page: https://510kreport.com/device/K140095
Methodology: https://510kreport.com/methodology