# K962942: Totalcare

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Feb 3, 1997 after 189 days
- Product code: FNL (Bed, Ac-Powered Adjustable Hospital)
- Device class: 2
- Regulation: 21 CFR 880.5100
- 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: 1 generation back to K915437 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K925576: Burke Bariatric Treatment System II, Burke Mobility Products (1993) Summary page 1.
- K915437: Critical Care Hospital Bed (Icu/Ccu), Hill-Rom, Inc. (1992) Summary page 1.

## Most influential descendants
- K122473: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2 (2013), 0 descendants of its own

## Recalls of this device
- Feb 23, 2017 · Class II · Z-1816-2017: The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient wei

## Indications for use
The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments. The product may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient

Source page: https://510kreport.com/device/K962942
Methodology: https://510kreport.com/methodology