510(k) · Cleared
ClearedAvita Bluetooth Blood Pressure Monitor, Model: BPM656ZB
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 Dec 7, 2007 as substantially equivalent to K040371 (A&D Engineering, Inc., 2004) after a 127-day review. Its family tree reaches back 2 generations to 1998. 16 later devices descend from it.
- Decided
- Dec 7, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982481 (1998). 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 1 generation backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- This deviceK072137 Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZBAvita Corporation · 2007
- Descendant · cites it directly · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 2 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · 2 generations on · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · 3 generations on · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · 4 generations on · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · cites it directly14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 2 generations on13descendants
- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · 2 generations on10descendants
- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · 3 generations on9descendants
- K181988eMurmur IDCsd Labs GmbH · 2019 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −1 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| 0 (this device) | K072137 | Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB | Avita Corporation | 2007 | — |
| +1 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +2 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +2 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +3 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +4 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K040371 | A & D Medical UA-767BT Digital Blood Pressure MonitorSummary page 1…Regulation Number: 2ICFR 870.1130 4. Predicate Device: The predicate device is the A&D Medical UA-767PBT Digital Blood Pressure Monitor(K040371) marketed by A & D ENGINEERING, INC.. 5. Intended Use: The device is arm type Blood Pressure Monito… | 2004 |
What descends from it? (16)
See all 162 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 9 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083309 (Zargis Medical Corp., 2009) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K040371.
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. 2007, 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 AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. At the end of each measurement, the results will be displayed on LCD. AViTA BPM656ZB through its Bluetooth wireless communication port can also transfer the measurement results to other electronic…
Read the full statement (123 words)
The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. At the end of each measurement, the results will be displayed on LCD. AViTA BPM656ZB through its Bluetooth wireless communication port can also transfer the measurement results to other electronic devices, such as a PC, a PDA or a printer.
The device is indicated for adult in home use. The arm circumference range shall be between 9 inches (23 cm) to 17 inches (43 cm). The end users should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072137: Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072137
Report an extraction error
Are you the manufacturer?
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