# K072516: Midmark Diagnostics Iqmark Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Diagnostics Group
- Decided: Oct 18, 2007 after 41 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: 8 generations back to K962603 (1997). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033048: Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, Cas Medical Systems, Inc. (2004) Summary page 1.
- K053027: VSM Vital Signs Monitor, Model 53000 (VSM 300), Welch Allyn, Inc. (2005) Summary page 1.
- K860436: Ivac Model 2080 Electronic Thermometer, Y (1986) Summary page 1.

## Most influential descendants
- K161909: IQvitals Zone (2016), 1 descendant of its own
- K253196: Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (2026), 0 descendants of its own

## Indications for use
The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only. The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.

Source page: https://510kreport.com/device/K072516
Methodology: https://510kreport.com/methodology