# K100913: Iqvitals and Iqvitals System

- Pathway: 510(k) (Traditional)
- Applicant: Brentwood Medical Technology Corp.
- Decided: May 26, 2010 after 55 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864318 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040012: Well@Home System, Zoe Medical, Inc. (2004) Summary page 1.

## Indications for use
The IQvitals and lQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SPO2), temperature and weight. Patient information such as name, age, height, pain score etc. can be entered manually.

Source page: https://510kreport.com/device/K100913
Methodology: https://510kreport.com/methodology