510(k) · Cleared
ClearedDigital Automatic Wrist Blood Pressure Monitor SWBPM22 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 Oct 31, 2014 as substantially equivalent to K133618 (Grandway Technology (Shenzhen) Limited, 2014) after a 91-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K012310 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK012310 Modification to:HL168D Blood Pressure MonitorHealth & Life Co., Ltd. · 2001
- 4 generations backK030230 Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Avita Corporation · 2003
- 3 generations backK110299 Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011
- 2 generations backK120673 Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013
- 1 generation backK133618 Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- This deviceK142088 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · cites it directly · 0 of its ownK163113 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2017
- Descendant · cites it directly · 0 of its ownK151587 Digital Automatic Wrist Blood Pressure Monitor MD3200Grandway Technology (Shenzhen) Limited · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K012310 | Modification to:HL168D Blood Pressure Monitor | Health & Life Co., Ltd. | 2001 | — |
| −4 | K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) | Avita Corporation | 2003 | — |
| −3 | K110299 | Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series | Grandway Technology (Shenzhen) Limited | 2011 | — |
| −2 | K120673 | Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series | Grandway Technology (Shenzhen) Limited | 2013 | — |
| −1 | K133618 | Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| 0 (this device) | K142088 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| +1 | K163113 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | 2017 | — |
| +1 | K151587 | Digital Automatic Wrist Blood Pressure Monitor MD3200 | Grandway Technology (Shenzhen) Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K133618 | Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesSummary page 4…ce Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series Manufacturer GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED 510(k) Number K133618 4. Device Description Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a non-invasive blood pressure measurement… | 2014 |
What descends from it? (2)
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 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K163113 (Grandway Technology (Shenzhen) Limited, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133618.
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. 2014, 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 wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142088: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142088
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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