# K093802: Ultraview DM3 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Zoe Medical, Inc.
- Decided: Apr 9, 2010 after 119 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 71 ancestors in all.
No later device cites it as a predicate yet.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software, Spacelabs Healthcare Medical Equipment (Suzhou) CO (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K095846: Model 2082 Temp Plus III Thermometer. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Aug 13, 2024 · Class II · Z-3098-2024: This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
- Jun 6, 2012 · Class II · Z-2380-2012: Unit fails to power up, resulting in an equipment alarm

## Indications for use
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SPO 2, pulse rate, NIBP, and temperature.

Source page: https://510kreport.com/device/K093802
Methodology: https://510kreport.com/methodology