# K071606: Biosign Central Station

- Pathway: 510(k) (Traditional)
- Applicant: Obs Medical
- Decided: Aug 31, 2007 after 80 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.
No later device cites it as a predicate yet.
0 of 22 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 2.

## Indications for use
The BioSign TM Central Station is an accessory to multi-parameter patient monitors (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. The BioSignTM Central Station provides the clinician with a patient status index (BioSign TM Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign TM index 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. The BioSignTM Central Station displays Bio Sign indices for multiple patients. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

Source page: https://510kreport.com/device/K071606
Methodology: https://510kreport.com/methodology