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 Jan 19, 2017 as substantially equivalent to K142088 (Grandway Technology (Shenzhen) Limited, 2014) after a 73-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jan 19, 2017
- Review
- 73 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K012310 (2001). No later device cites it as a predicate yet.
- Root · 6 generations backK012310 Modification to:HL168D Blood Pressure MonitorHealth & Life Co., Ltd. · 2001
- 5 generations backK030230 Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Avita Corporation · 2003
- 4 generations backK110299 Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011
- 3 generations backK120673 Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013
- 2 generations backK133618 Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- 1 generation backK142088 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- This deviceK163113 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K012310 | Modification to:HL168D Blood Pressure Monitor | Health & Life Co., Ltd. | 2001 | — |
| −5 | K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) | Avita Corporation | 2003 | — |
| −4 | K110299 | Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series | Grandway Technology (Shenzhen) Limited | 2011 | — |
| −3 | 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 | — |
| −1 | K142088 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| 0 (this device) | K163113 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | 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 |
|---|---|---|---|
| * | K142088 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesSummary page 5…N) 3. Predicate device Predicate Device Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series Manufacturer GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED 510(k) Number K142088 4. Device Description Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a non-invasive blood pressure measuremen… | 2014 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K142088.
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 wrist.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163113 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163113: 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 4, 2026. https://510kreport.com/device/K163113
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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