# K202964: iBed Wireless with iBed Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jun 18, 2021 after 261 days
- Product code: FNL (Bed, Ac-Powered Adjustable Hospital)
- Device class: 2
- Regulation: 21 CFR 880.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925529 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103536: Ibed Wireless with Ibed Awareness, Stryker Corporation (2010) Summary page 4.

## Indications for use
The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization’s campus. The iBed™ Wireless with iBed™ Mobile accessory is intended to be used only with Stryker Medical’s AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

Source page: https://510kreport.com/device/K202964
Methodology: https://510kreport.com/methodology
