510(k) · Cleared
ClearedGoldway UT4000A Vital Signs Monitor
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 Feb 25, 2004 as substantially equivalent to K021154 (Goldway Us, Inc., 2003) after a 64-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Feb 25, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021154 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK021154 Goldway Patient Monitor, Model # UT4000FGoldway Us, Inc. · 2003
- This deviceK033988 Goldway UT4000A Vital Signs MonitorGoldway (Us), Inc. · 2004
- Descendant · cites it directly · 1 of its ownK112877 Comen Multi-Parameter Patient MonitorGoldway (Us), Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK173454 Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021154 | Goldway Patient Monitor, Model # UT4000F | Goldway Us, Inc. | 2003 | — |
| 0 (this device) | K033988 | Goldway UT4000A Vital Signs Monitor | Goldway (Us), Inc. | 2004 | — |
| +1 | K112877 | Comen Multi-Parameter Patient Monitor | Goldway (Us), Inc. | 2012 | — |
| +2 | K173454 | Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co.,Ltd | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021154 | Goldway Patient Monitor, Model # UT4000FSummary page 1…logical, Patient 3. Predicate Device Information: The legally marketed device to which the submitter claims equivalence: Goldway Model UT4000F Patient Monitor (K021154) 4. Device Description: The Goldway UT4000A monitor interprets and displays physiological data of the patient includin… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112877 | Comen Multi-Parameter Patient Monitor | 2012 | 1 |
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?
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?
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…
Read the full statement (111 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033988: Goldway UT4000A Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033988
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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