510(k) · Cleared
ClearedAvita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avita Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 23, 2003 as substantially equivalent to K012310 (Health & Life Co., Ltd., 2001) after a 121-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 121 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012310 (2001). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK012310 Modification to:HL168D Blood Pressure MonitorHealth & Life Co., Ltd. · 2001
- This deviceK030230 Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Avita Corporation · 2003
- Descendant · cites it directly · 7 of its ownK110299 Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011
- Descendant · 2 generations on · 6 of its ownK120673 Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013
- Descendant · 3 generations on · 5 of its ownK133618 Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · 4 generations on · 2 of its ownK142088 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · 4 generations on · 1 of its ownK143733 Digital Automatic Wrist Blood Pressure Monitor MD2400Grandway Technology (Shenzhen) Limited · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K110299Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011 · cites it directly7descendants
- K120673Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013 · 2 generations on6descendants
- K133618Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 3 generations on5descendants
- K142088Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 4 generations on2descendants
- K143733Digital Automatic Wrist Blood Pressure Monitor MD2400Grandway Technology (Shenzhen) Limited · 2015 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012310 | Modification to:HL168D Blood Pressure Monitor | Health & Life Co., Ltd. | 2001 | — |
| 0 (this device) | K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) | Avita Corporation | 2003 | — |
| +1 | 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 | — |
| +3 | K133618 | Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| +4 | K142088 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| +4 | K143733 | Digital Automatic Wrist Blood Pressure Monitor MD2400 | Grandway Technology (Shenzhen) Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012310 | Modification to:HL168D Blood Pressure Monitor | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110299 | Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series | 2011 | 7 |
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?
- Its one ancestor has no recall.
- Of its descendants, K110299 (Grandway Technology (Shenzhen) Limited, 2011) has gone furthest, with 7 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.
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?
The device is noninvasive and provide systolic, diastolic blood pressure and pulse rateiieart rate) measurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD panel. The device is indicated for use by people over 15 years old in home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030230: Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030230
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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