510(k) · Cleared
ClearedDigital Automatic Blood Pressure Monitor MD36 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grandway Technology (Shenzhen) Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 22, 2019 as substantially equivalent to K163679 (Grandway Technology (Shenzhen) Limited, 2017) after a 38-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 22, 2019
- Review
- 38 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001670 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 5 generations backK033397 Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XYAvita Corporation · 2004
- 4 generations backK120675 Digital Automatic Blood Pressure Monitor BPM11 SeriesGrandway Technology (Shenzhen) Limited · 2013
- 3 generations backK133619 Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 2014
- 2 generations backK143735 Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited · 2015
- 1 generation backK163679 Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 2017
- This deviceK191593 Digital Automatic Blood Pressure Monitor MD36 SeriesGrandway Technology (Shenzhen) Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −5 | K033397 | Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY | Avita Corporation | 2004 | — |
| −4 | K120675 | Digital Automatic Blood Pressure Monitor BPM11 Series | Grandway Technology (Shenzhen) Limited | 2013 | — |
| −3 | K133619 | Digital Automatic Blood Pressure Monitor BPM18 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| −2 | K143735 | Digital Automatic Blood Pressure Monitor MD2300 | Grandway Technology (Shenzhen) Limited | 2015 | — |
| −1 | K163679 | Digital Automatic Blood Pressure Monitor MD3600 | Grandway Technology (Shenzhen) Limited | 2017 | — |
| 0 (this device) | K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | Grandway Technology (Shenzhen) Limited | 2019 | — |
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 |
|---|---|---|---|
| * | K163679 | Digital Automatic Blood Pressure Monitor MD3600Summary page 4…Digital Automatic Blood Pressure Monitor MD3600 Manufacturer GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED 510(k) Number K163679 4. Device Description Digital Automatic Blood Pressure Monitor MD36 Series (Subject Device) are non-invasive blood pressure meas… | 2017 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 6 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. 2019, 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 upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191593: Digital Automatic Blood Pressure Monitor MD36 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191593
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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