510(k) · Cleared
ClearedKD-575 Memory Automatic Electronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kodon (Tianjin)Electronic&Electrical Apparatus Co., · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 21, 2005 as substantially equivalent to K030358 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2003) after a 199-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Mar 21, 2005
- Review
- 199 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001670 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 1 generation backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- This deviceK042418 KD-575 Memory Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2005
- Descendant · cites it directly · 1 of its ownK083395 Semi-Fully Automatic Electronic Blood Pressure Monitor, Models…Andon Health Co, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK091738 Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BDAndon Health Co, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK080789 Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202Sejoy Electronics & Instruments Co., Ltd. · 2008
Most influential descendants
Showing 3 of 3 · See all- K083395Semi-Fully Automatic Electronic Blood Pressure Monitor, Models…Andon Health Co, Ltd. · 2009 · cites it directly1descendant
- K091738Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BDAndon Health Co, Ltd. · 2009 · 2 generations on0descendants
- K080789Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202Sejoy Electronics & Instruments Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −1 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| 0 (this device) | K042418 | KD-575 Memory Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2005 | — |
| +1 | K083395 | Semi-Fully Automatic Electronic Blood Pressure Monitor, Models… | Andon Health Co, Ltd. | 2009 | — |
| +2 | K091738 | Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BD | Andon Health Co, Ltd. | 2009 | — |
| +1 | K080789 | Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202 | Sejoy Electronics & Instruments Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K030358 | KD-622 Fully Automatic Electronic Blood Pressure MonitorSummary page 1…vice manufacture 510(k) number KD-622 Kodon (Tianjin) Electronic and Electrical K030358 Apparatus Co., Ltd. Device description: KD-575 Fully Automatic Electronic Blood Pressure Monitor is a Non-inva… | 2003 |
What descends from it? (3)
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 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083395 (Andon Health Co, Ltd., 2009) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K030358.
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 KD-575 Memory Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive, technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042418: KD-575 Memory Automatic Electronic 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/K042418
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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