510(k) · Cleared
ClearedKD-788 Wrist Measurement 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 Feb 28, 2006 as substantially equivalent to K030359 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2003) after a 174-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 28, 2006
- Review
- 174 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001671 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001671 Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model…Omron Healthcare, Inc. · 2000
- 1 generation backK030359 KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- This deviceK052450 KD-788 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2006
- Descendant · cites it directly · 2 of its ownK123130 Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK213699 CareTaker Monitor AppCaretaker Medical, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK201914 HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013 · cites it directly2descendants
- K213699CareTaker Monitor AppCaretaker Medical, LLC · 2022 · 2 generations on0descendants
- K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001671 | Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630 | Omron Healthcare, Inc. | 2000 | — |
| −1 | K030359 | KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| 0 (this device) | K052450 | KD-788 Wrist Measurement Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2006 | — |
| +1 | K123130 | Answatch Wrist Monitor Model TS-0411 | Taiwan Scientific Corporation | 2013 | — |
| +2 | K213699 | CareTaker Monitor App | Caretaker Medical, LLC | 2022 | — |
| +2 | K201914 | HRVWatch-Mini Wrist Monitor | Taiwan Scientific Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K030359 | KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorSummary page 1…imed: Device manufacture 510(k) number KD-726 Kodon (Tianjin) Electronic and K030359 Electrical Co., Ltd. Device description: KD-788 Wrist Measurement Blood Pressure Monitor is a Non-invasive bl… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123130 | Answatch Wrist Monitor Model TS-0411 | 2013 | 2 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123130 (Taiwan Scientific Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K030359.
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-788 Wrist Measurement 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052450: KD-788 Wrist Measurement 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/K052450
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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