510(k) · Cleared
ClearedDigital Automatic Blood Pressure Monitor BPM11 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 Feb 14, 2013 as substantially equivalent to K033397 (Avita Corporation, 2004) after a 346-day review. Its family tree reaches back 2 generations to 2000. 10 later devices descend from it.
- Decided
- Feb 14, 2013
- Review
- 346 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001670 (2000). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 1 generation backK033397 Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XYAvita Corporation · 2004
- This deviceK120675 Digital Automatic Blood Pressure Monitor BPM11 SeriesGrandway Technology (Shenzhen) Limited · 2013
- Descendant · cites it directly · 8 of its ownK133619 Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · 2 generations on · 3 of its ownK143735 Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited · 2015
- Descendant · 3 generations on · 1 of its ownK163679 Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 2017
- Descendant · 2 generations on · 1 of its ownK150373 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model…Grandway Technology (Shenzhen) Limited · 2015
- Descendant · 4 generations on · 0 of its ownK191593 Digital Automatic Blood Pressure Monitor MD36 SeriesGrandway Technology (Shenzhen) Limited · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133619Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 2014 · cites it directly8descendants
- K143735Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited · 2015 · 2 generations on3descendants
- K163679Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 2017 · 3 generations on1descendant
- K150373Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]Grandway Technology (Shenzhen) Limited · 2015 · 2 generations on1descendant
- K191593Digital Automatic Blood Pressure Monitor MD36 SeriesGrandway Technology (Shenzhen) Limited · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −1 | K033397 | Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY | Avita Corporation | 2004 | — |
| 0 (this device) | K120675 | Digital Automatic Blood Pressure Monitor BPM11 Series | Grandway Technology (Shenzhen) Limited | 2013 | — |
| +1 | 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 | — |
| +3 | K163679 | Digital Automatic Blood Pressure Monitor MD3600 | Grandway Technology (Shenzhen) Limited | 2017 | — |
| +2 | K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.… | Grandway Technology (Shenzhen) Limited | 2015 | — |
| +4 | K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | Grandway Technology (Shenzhen) Limited | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K033397 | Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XYSummary page 1…DEVICEMANUFACTURER I510(k) Number AViTA BPM6 Series Blood Pressure Meter AViTA Corp K033397 Device Description Digital Automatic Blood Pressure Monitor BPM11 Series is a non-invasive blood pressure measurement sys… | 2004 |
What descends from it? (10)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133619 (Grandway Technology (Shenzhen) Limited, 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K033397.
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. 2013, 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?
Digital Automatic Blood Pressure Monitor BPM1 1 Series is for use by medical professional or at home. The BPM1 1 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm- 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120675: Digital Automatic Blood Pressure Monitor BPM11 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120675
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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