# K021154: Goldway Patient Monitor, Model # UT4000F

- Pathway: 510(k) (Traditional)
- Applicant: Goldway Us, Inc.
- Decided: Apr 11, 2003 after 366 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101052: Omni Iii Patient Monitor (2010), 6 descendants of its own
- K103268: Omni Express (2010), 5 descendants of its own
- K103737: Omni II Patient Monitor (2011), 4 descendants of its own
- K112329: Omni Patient Monitor (2011), 3 descendants of its own
- K132229: Omni Patent Monitors (2014), 2 descendants of its own

## Indications for use
The patient monitor is intended to monitor the basic physiological parameters of the patient under the direct supervision of a licensed healthcare practitioner. It can be used for all patients from Adult to Neonatal. The monitor is designed as a bedside or portable monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities. The UT 4000F is not intended for use as an apnea monitor. The UT 4000F is not intended for use during IMRI or CT scans. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and carbon dioxide. The UT 4000F Patient Monitor is also intended to provide physiological data over a network to clinical information systems and allow the user to access hospital data at the point of care.

Source page: https://510kreport.com/device/K021154
Methodology: https://510kreport.com/methodology