# K081140: Visensia

- Pathway: 510(k) (Traditional)
- Applicant: Obs Medical
- Decided: Jul 17, 2008 after 86 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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). 34 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030267: Eeg Monitor with Bis, Model a-2000, Aspect Medical Systems, Inc. (2004) Summary page 2.
- 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 3.
- K061993: Equivital, Model EQ-01, Hidalgo Limited (2006) Summary page 3.

## Most influential descendants
- K110953: Visensia, Visensia with Alert (2011), 17 descendants of its own
- K152258: T3 Software (2016), 16 descendants of its own
- K163065: T3 Software (2017), 15 descendants of its own
- K190273: T3 Platform software (2019), 14 descendants of its own
- K202306: T3 Platform software (2020), 13 descendants of its own

## Indications for use
Visensia® with Alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-paediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or four vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia® with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status. When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.

Source page: https://510kreport.com/device/K081140
Methodology: https://510kreport.com/methodology