510(k) · Cleared
ClearedGoldway Patient Monitor, Model # UT4000F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Goldway Us, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Apr 11, 2003 after a 366-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Apr 11, 2003
- Review
- 366 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK021154 Goldway Patient Monitor, Model # UT4000FGoldway Us, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK101052 Omni Iii Patient MonitorInfinium Medical · 2010
- Descendant · 2 generations on · 5 of its ownK103268 Omni ExpressInfinium Medical · 2010
- Descendant · 3 generations on · 4 of its ownK103737 Omni II Patient MonitorInfinium Medical · 2011
- Descendant · 4 generations on · 3 of its ownK112329 Omni Patient MonitorInfinium Medical · 2011
- Descendant · 2 generations on · 2 of its ownK132229 Omni Patent MonitorsInfinium Medical · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K101052Omni Iii Patient MonitorInfinium Medical · 2010 · cites it directly6descendants
- K103268Omni ExpressInfinium Medical · 2010 · 2 generations on5descendants
- K103737Omni II Patient MonitorInfinium Medical · 2011 · 3 generations on4descendants
- K112329Omni Patient MonitorInfinium Medical · 2011 · 4 generations on3descendants
- K132229Omni Patent MonitorsInfinium Medical · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021154 | Goldway Patient Monitor, Model # UT4000F | Goldway Us, Inc. | 2003 | — |
| +1 | K101052 | Omni Iii Patient Monitor | Infinium Medical | 2010 | — |
| +2 | K103268 | Omni Express | Infinium Medical | 2010 | — |
| +3 | K103737 | Omni II Patient Monitor | Infinium Medical | 2011 | — |
| +4 | K112329 | Omni Patient Monitor | Infinium Medical | 2011 | — |
| +2 | K132229 | Omni Patent Monitors | Infinium Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101052 (Infinium Medical, 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021154: Goldway Patient Monitor, Model # UT4000F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026