510(k) · Cleared
ClearedBluetooth blood pressure monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visiomed Group SA · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 26, 2018 as substantially equivalent to K133125 (Withings, 2014) after a 266-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Feb 26, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001670 (2000). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 5 generations between
- 3 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 2 generations backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- 1 generation backK133125 Withings Blood Presure MonitorWithings · 2014 · Recalled
- This deviceK171668 Bluetooth blood pressure monitorVisiomed Group SA · 2018
Show all 9 generations
- Root · 9 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 8 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 7 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 6 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 5 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 4 generations backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 3 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 2 generations backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- 1 generation backK133125 Withings Blood Presure MonitorWithings · 2014 · Recalled
- This deviceK171668 Bluetooth blood pressure monitorVisiomed Group SA · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −8 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −7 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −6 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −5 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −4 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −3 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| −2 | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| −1 | K133125 | Withings Blood Presure Monitor | Withings | 2014 | 1 |
| 0 (this device) | K171668 | Bluetooth blood pressure monitor | Visiomed Group SA | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K133125 | Withings Blood Presure MonitorSummary page 4…DEVICE Device Name: Withings Blood Pressure Monitor, Upper Arm Type BP-801 Common/Usual Name: Blood Pressure Monitor, Upper Arm Type BP-801 510(k) Number: K133125 510(k) submitter/holder: Withings (VA HORNG Electronic Co., Ltd.) IV. DEVICE DESCRIPTION BW-BA1 Bluetooth Blood Pressure… | 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 18 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K133125.
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. 2018, 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?
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches to 16.5 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult…
Read the full statement (122 words)
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches to 16.5 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby.
It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171668: Bluetooth blood pressure monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171668
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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