510(k) · Cleared
ClearedHappy Health Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Happy Health, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 3, 2026 as substantially equivalent to K250415 (Aktiia SA, 2025) after a 262-day review. Its family tree reaches back 12 generations to 1997.
- Decided
- Sep 3, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K962603 (1997). 84 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet.
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations between
- 3 generations backK113165 Mini-MedicAthena Gtx · 2012
- 2 generations backK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- 1 generation backK250415 G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025
- This deviceK254000 Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 10 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 9 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 8 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 7 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 6 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 5 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 4 generations backK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- 3 generations backK113165 Mini-MedicAthena Gtx · 2012
- 2 generations backK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- 1 generation backK250415 G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025
- This deviceK254000 Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −11 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −10 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −9 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −8 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −7 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −6 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −5 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −4 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
| −3 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| −2 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| −1 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025 | — |
| 0 (this device) | K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K250415 | G0 Blood Pressure Monitoring System (G0)Summary page 5…ive Regulation Number: 870.1130 Product Code(s): DXN PREDICATE DEVICE Primary Predicate Device Name: G0 Blood Pressure Monitoring System (K250415) Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Regulation Number: 870.1130 Product Code(s):… | 2025 |
| † | K201302 | LiveOne | 2022 |
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 29 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 12 of the 84 ancestors have a recall of any class.
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. 2026, 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?
The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring. The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or…
Read the full statement (143 words)
The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring.
The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or clinical setting.
The Happy Health Blood Pressure Monitor is intended only for measurement and display; it makes no diagnosis. The device should not be used by individuals with arrhythmias such as atrial fibrillation, severe vascular disease or radial-artery abnormalities (e.g., Raynaud’s syndrome), under vasoactive drugs, or those who are pregnant. The Happy Health Blood Pressure Monitor is not intended to be used in conditions of motion or low perfusion.
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/K254000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254000: Happy Health Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254000
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026