510(k) · Cleared
ClearedDigital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 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 7, 2017 as substantially equivalent to K150373 (Grandway Technology (Shenzhen) Limited, 2015) after a 196-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Jul 7, 2017
- Review
- 196 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001670 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 4 generations backK033397 Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XYAvita Corporation · 2004
- 3 generations backK120675 Digital Automatic Blood Pressure Monitor BPM11 SeriesGrandway Technology (Shenzhen) Limited · 2013
- 2 generations backK133619 Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 2014
- 1 generation backK150373 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model…Grandway Technology (Shenzhen) Limited · 2015
- This deviceK163648 Digital Automatic Blood Pressure Monitor BPM41 Series, Digital…Grandway Technology (Shenzhen) Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −4 | K033397 | Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY | Avita Corporation | 2004 | — |
| −3 | K120675 | Digital Automatic Blood Pressure Monitor BPM11 Series | Grandway Technology (Shenzhen) Limited | 2013 | — |
| −2 | K133619 | Digital Automatic Blood Pressure Monitor BPM18 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| −1 | K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.… | Grandway Technology (Shenzhen) Limited | 2015 | — |
| 0 (this device) | K163648 | Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood… | Grandway Technology (Shenzhen) Limited | 2017 | — |
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 |
|---|---|---|---|
| * | K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]Summary page 4…Digital Automatic Blood Pressure Monitor BPM25 & BPM 26 Series Manufacturer GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED 510(k) Number K150373 4. Device Description Digital Automatic Blood Pressure Monitor BPM41 Series and Digital Automatic Blood Pressure Monitor BPM45 S… | 2015 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 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. 2017, 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?
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163648: Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163648
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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