# K110953: Visensia, Visensia with Alert

- Pathway: 510(k) (Special)
- Applicant: Obs Medical
- Decided: Jun 15, 2011 after 71 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: 7 generations back to K962603 (1997). 35 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081140: Visensia, Obs Medical (2008) Summary page 2.

## Most influential descendants
- 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
- K213230: T3 Platform Software (2022), 12 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-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. Visensia® provides the clinician wit 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@ is an adjunct to and is not intended to replace vital sign monitoring. When a Visensia® alert has activated, it means that the Visensia® Index has reached and/or surpassed the default ihreshold and indicates that attention should be brought to the patient.

Source page: https://510kreport.com/device/K110953
Methodology: https://510kreport.com/methodology