# K253196: Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corporation
- Decided: Jun 12, 2026 after 259 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: 23 generations back to K962603 (1997). 103 ancestors in all.
No later device cites it as a predicate yet.
2 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161909: IQvitals Zone, Midmark Corporation (2016) Summary page 5.
- K193242: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories, Masimo Corporation (2020) Summary page 5.

## Indications for use
The Midmark 800 Digital Vital Signs Device is intended for use by clinicians and other medically qualified personnel to measure specific physiologic parameters in adult and pediatric patients. The device provides the following non-invasive measurements for patients 2 years and older, unless otherwise specified: * Non-Invasive Blood Pressure (NIBP): for patients aged 3 years and older * Pulse Rate * Body Temperature (temporal artery) * Functional Oxygen Saturation (SpO₂ - optional) * Respiration Rate from Photoplethysmogram (RRp - optional) The Midmark 800 Digital Vital Signs Device is intended for screening, spot-checking, or confirmation of vital signs, with data transfer to an electronic medical record (EMR) system. It is indicated for use in ambulatory care clinics, hospitals, and other points of care, under the direction of trained medical personnel.

Source page: https://510kreport.com/device/K253196
Methodology: https://510kreport.com/methodology