510(k) · Cleared
ClearedGlobalcare Blood Pressure Monitor (GUS610)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globalcare Medical Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 8, 2025 as substantially equivalent to K222160 (Globalcare Medical Technology Co., Ltd., 2022) after an 81-day review. Its family tree reaches back 11 generations to 2000.
- Decided
- Apr 8, 2025
- Review
- 81 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001670 (2000). No later device cites it as a predicate yet.
- Root · 11 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 7 generations between
- 3 generations backK141984 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015
- 2 generations backK192609 Globalcare Blood Pressure MonitorGlobalcare Medical Technology Co., Ltd. · 2020
- 1 generation backK222160 GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd. · 2022
- This deviceK250136 Globalcare Blood Pressure Monitor (GUS610)Globalcare Medical Technology Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 10 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 9 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 8 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 7 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 6 generations backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 5 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 4 generations backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- 3 generations backK141984 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2015
- 2 generations backK192609 Globalcare Blood Pressure MonitorGlobalcare Medical Technology Co., Ltd. · 2020
- 1 generation backK222160 GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd. · 2022
- This deviceK250136 Globalcare Blood Pressure Monitor (GUS610)Globalcare Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −10 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −9 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −8 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −7 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −6 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −5 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| −4 | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| −3 | K141984 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2015 | — |
| −2 | K192609 | Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd. | 2020 | — |
| −1 | K222160 | GUS610 Blood pressure monitor | Globalcare Medical Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. | 2025 | — |
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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K222160 | GUS610 Blood pressure monitorSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code K222160 Globacare GUS610 Blood Pressure Monitor DXN IDevice Description Summary… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Globalcare GUS610 automatic Blood Pressure Monitor is indicated for home use for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 52 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250136 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250136: Globalcare Blood Pressure Monitor (GUS610).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250136
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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