# K223246: Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corproration
- Decided: Nov 18, 2022 after 29 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K910772 (1991). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202018: Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation, Hill-Rom, Inc. (2021) Summary page 5.

## Indications for use
The Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) and heart rate (HR) in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lb (318 kg). NOTE: Do not exceed the limit of the bed system for weight, population, or use setting.

Source page: https://510kreport.com/device/K223246
Methodology: https://510kreport.com/methodology