# K180380: vital signs monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 21, 2018 after 312 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K102835 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131818: Vital Signs Monitor, Edan Instruments, Inc. (2013) Summary page 4.

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1143-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

## Indications for use
The monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments. Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP. The monitor is not intended for MRI environments. TEMP module is not intended for neonates.

Source page: https://510kreport.com/device/K180380
Methodology: https://510kreport.com/methodology