# K103536: Ibed Wireless with Ibed Awareness

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Dec 16, 2010 after 15 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: 3 generations back to K925529 (1993). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922352: The Advance Series From Hill-Rom, Hill-Rom, Inc. (1992) Summary page 1.
- K101109: Vivatrak, Wireless Medcare, LLC (2010)

## Most influential descendants
- K202964: iBed Wireless with iBed Mobile (2021), 0 descendants of its own
- K143414: Hill-Rom Wireless Connectivity Module (2015), 0 descendants of its own
- K122473: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2 (2013), 0 descendants of its own

## Indications for use
The intended use for the iBedTm Wireless (with iBedTh Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBedTM Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed1 ~" Wireless software, and is not intended to provide bed status information for non-Stryker beds. The iBedTm Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBedTm Wireless with iBedTh Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed"" Wireless with iiBedTh Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Source page: https://510kreport.com/device/K103536
Methodology: https://510kreport.com/methodology