# K033988: Goldway UT4000A Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Goldway (Us), Inc.
- Decided: Feb 25, 2004 after 64 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: 1 generation back to K021154 (2003). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021154: Goldway Patient Monitor, Model # UT4000F, Goldway Us, Inc. (2003) Summary page 1.

## Most influential descendants
- K112877: Comen Multi-Parameter Patient Monitor (2012), 1 descendant of its own
- K173454: Multi-parameter Patient Monitor, models C30 (2018), 0 descendants of its own

## Indications for use
Goldway UT4000A Vital Signs Monitor is intended to monitor basic physiological parameters of patients from adults to neonates within any professional medical environment. The user, responsible to interpret the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data analysis will be made available to the user from the monitor. Physiological data includes: electrocardiograph, non-invasive blood pressure, and pulse oximetry. Goldway UT4000A is not intended fof use as an apnea monitor. Goldway UT4000A is not intended for use during MRI or CT scans. The UT4000A is not designed for home use. The device is restricted to be used on one patient at a time.

Source page: https://510kreport.com/device/K033988
Methodology: https://510kreport.com/methodology