510(k) · Cleared
ClearedQardioarm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qardio, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 18, 2014 as substantially equivalent to K120672 (Andon Health Co, Ltd., 2012) and 1 other predicate after a 159-day review. Its family tree reaches back 8 generations to 2000. 8 later devices descend from it.
- Decided
- Jun 18, 2014
- Review
- 159 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001670 (2000). 16 ancestors in all, the oldest K982481 (1998). 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 7 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 6 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 5 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 4 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 3 generations backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 2 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 1 generation backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- This deviceK140067 QardioarmQardio, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK171833 Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK220651 Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK230409 Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd. · 2023
- Descendant · 5 generations on · 0 of its ownK253570 Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · cites it directly6descendants
- K171833Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018 · 2 generations on4descendants
- K220651Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd. · 2022 · 3 generations on2descendants
- K230409Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd. · 2023 · 4 generations on1descendant
- K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −7 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −6 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −5 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −4 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −3 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −2 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| −1 | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| 0 (this device) | K140067 | Qardioarm | Qardio, Inc. | 2014 | — |
| +1 | K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Fudakang Industrial Co., Ltd. | 2015 | — |
| +2 | K171833 | Digital Blood Pressure Monitor-Wrist Style | Shenzhen Combei Technology Co., Ltd. | 2018 | — |
| +3 | K220651 | Wrist Type Blood Pressure Monitor | Shenzhen Jamr Medical Technology Co., Ltd. | 2022 | — |
| +4 | K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L) | Shenzhen Jamr Technology Co., Ltd. | 2023 | — |
| +5 | K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K120672 | KD-936 Fully Automatic Wireless Blood Pressure MonitorSummary page 3…A10O BP700W KD-936 510K number New listing K121025 K120672 Technological Oiscillometric method Oscillometric method Oscillometric method character… | 2012 |
| * | K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionSummary page 3…e Dock Model name A10O BP700W KD-936 510K number New listing K121025 K120672 Technological Oiscillometric method Oscillometric method Os… | 2012 |
| † | K051539 | Tricot Blood Pressure Cuff | 2005 |
What descends from it? (8)
2 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 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K150430 (Fudakang Industrial Co., Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K120672.
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. 2014, 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?
QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm.
This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140067: Qardioarm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140067
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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