510(k) · Cleared
ClearedDigital Automatic Wrist Blood Pressure Monitor WBPM10 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 Mar 21, 2011 as substantially equivalent to K030230 (Avita Corporation, 2003) after a 48-day review. Its family tree reaches back 2 generations to 2001. 7 later devices descend from it.
- Decided
- Mar 21, 2011
- Review
- 48 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012310 (2001). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK012310 Modification to:HL168D Blood Pressure MonitorHealth & Life Co., Ltd. · 2001
- 1 generation backK030230 Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Avita Corporation · 2003
- This deviceK110299 Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011
- Descendant · cites it directly · 6 of its ownK120673 Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013
- Descendant · 2 generations on · 5 of its ownK133618 Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · 3 generations on · 2 of its ownK142088 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · 3 generations on · 1 of its ownK143733 Digital Automatic Wrist Blood Pressure Monitor MD2400Grandway Technology (Shenzhen) Limited · 2015
- Descendant · 4 generations on · 0 of its ownK171379 Digital Automatic Wrist Blood Pressure Monitor MD4300Grandway Technology (Shenzhen) Limited · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120673Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013 · cites it directly6descendants
- K133618Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 2 generations on5descendants
- K142088Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 3 generations on2descendants
- K143733Digital Automatic Wrist Blood Pressure Monitor MD2400Grandway Technology (Shenzhen) Limited · 2015 · 3 generations on1descendant
- K171379Digital Automatic Wrist Blood Pressure Monitor MD4300Grandway Technology (Shenzhen) Limited · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012310 | Modification to:HL168D Blood Pressure Monitor | Health & Life Co., Ltd. | 2001 | — |
| −1 | K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) | Avita Corporation | 2003 | — |
| 0 (this device) | K110299 | Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series | Grandway Technology (Shenzhen) Limited | 2011 | — |
| +1 | K120673 | Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series | Grandway Technology (Shenzhen) Limited | 2013 | — |
| +2 | K133618 | Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| +3 | K142088 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| +3 | K143733 | Digital Automatic Wrist Blood Pressure Monitor MD2400 | Grandway Technology (Shenzhen) Limited | 2015 | — |
| +4 | K171379 | Digital Automatic Wrist Blood Pressure Monitor MD4300 | Grandway Technology (Shenzhen) Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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 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 |
|---|---|---|---|
| * | K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Summary page 1…DEVICE MANUFACTURER 510(k) Number AViTA BPM1 Series (Wrist Type) Blood AViTA Corp K030230 Pressure Meter (or Monitor) ____________________ Device Description Digital Automatic Wrist Blood Pressure… | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120673 | Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series | 2013 | 6 |
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 10 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120673 (Grandway Technology (Shenzhen) Limited, 2013) has gone furthest, with 6 descendants of its own.
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. 2011, 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 Wrist Blood Pressure Monitor WBPM1O Series is for use by medical professional or at home. The WBPM1O 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 wrist of an individual.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110299 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110299: Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110299
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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