# K161909: IQvitals Zone

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corporation
- Decided: Nov 17, 2016 after 128 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 68 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072516: Midmark Diagnostics Iqmark Vital Signs Monitor, Midmark Diagnostics Group (2007) Summary page 4.
- K101445: Vital Signs Monitor-VSM 6000 Series, Welch Allyn, Inc. (2010) Summary page 4.
- K060576: Nellcor Oximax N-600X Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2006) Summary page 4.
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 4.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Aug 21, 2026 · Class II · Z-3218-2026: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Aug 21, 2026 · Class II · Z-3217-2026: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Aug 21, 2026 · Class II · Z-3219-2026: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Aug 21, 2026 · Class II · Z-3220-2026: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

## Indications for use
The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring: • Noninvasive blood pressure for adult and pediatric patients (3 years and above) • Pulse rate for adult and pediatric patients • Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients • Body temperature measured at Temporal Artery for adult and pediatric patients The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.

Source page: https://510kreport.com/device/K161909
Methodology: https://510kreport.com/methodology