# K053112: Biosign

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Biosignals Limited
- Decided: Jan 31, 2006 after 88 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: 5 generations back to K962603 (1997). 20 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 2.
- K992607: Sonicaid System 8002, Oxford Instruments Medical Systems (2001) Summary page 2.
- K030267: Eeg Monitor with Bis, Model a-2000, Aspect Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K142512: Personalized Physiology Analytics Engine software (2015), 3 descendants of its own
- K183282: Biovitals Analytics Engine (2019), 2 descendants of its own
- K124038: Bedside Paediatric Early Warning System (Bedsidepews) (2013), 2 descendants of its own
- K230386: SpassageQ (2023), 1 descendant of its own
- K172959: PeraServer and PeraTrend (2018), 1 descendant of its own

## Indications for use
BioSign TM is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. BioSign T M provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status indexTM is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign TM is an adjunct to and is not intended to replace vital signs monitoring

Source page: https://510kreport.com/device/K053112
Methodology: https://510kreport.com/methodology