# K124038: Bedside Paediatric Early Warning System (Bedsidepews)

- Pathway: 510(k) (Traditional)
- Applicant: Bedside Clinical Systems, Inc.
- Decided: Jun 21, 2013 after 175 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053112: Biosign, Oxford Biosignals Limited (2006) Summary page 1.

## Most influential descendants
- K172959: PeraServer and PeraTrend (2018), 1 descendant of its own
- K183370: PeraMobile and PeraWatch (2019), 0 descendants of its own

## Indications for use
The Bedside Paediatric Early Warning System (BedsidePEWS™) is an electronic documentation tool that is designed to be used in conjunction with multi-parameter patient monitoring. It is indicated for use by healthcare professionals with paediatric patients between the ages of term newborn (>37 weeks gestational age) and 18 years, who are hospitalized with any medical or surgical condition. BedsidePEWS™ allows input by the healthcare professional of commonly recorded vital sign data and provides clinician with a patient status index (the “BedsidePEWS™ score”) based on a weighted average of seven vital signs when entered by the clinician, namely Heart Rate, Respiratory Rate, Blood Pressure, Oxygen Saturation, Oxygen Therapy, Respiratory Effort, and Capillary Refill. The “BedsidePEWS™ score” is a single measure of a patient’s condition and indicates the variation in the patient’s vital signs with respect to normality. BedsidePEWS™ is an adjunct to and is not intended to replace vital signs monitoring. BedsidePEWS™ is intended for use in wards and emergency rooms in hospitals that provide care for children between the ages of term newborn (>37 weeks gestational age) and 18 years. It is not intended for use in the Neonatal Intensive Care Unit.

Source page: https://510kreport.com/device/K124038
Methodology: https://510kreport.com/methodology