510(k) · Cleared
ClearedBP652N (Hem-6300-Z)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 21, 2013 as substantially equivalent to K042505 (Omron Healthcare, Inc., 2005) after a 128-day review. Its family tree reaches back 1 generation to 2005. 21 later devices descend from it.
- Decided
- Mar 21, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042505 (2005). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- This deviceK123498 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013
- Descendant · cites it directly · 19 of its ownK142917 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK182166 Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK160557 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- Descendant · 4 generations on · 2 of its ownK230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2023
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K142917BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014 · cites it directly19descendants
- K182166Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc. · 2018 · 2 generations on10descendants
- K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2022 · 3 generations on5descendants
- K160557Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016 · 2 generations on3descendants
- K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| 0 (this device) | K123498 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2013 | — |
| +1 | K142917 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2014 | — |
| +2 | K182166 | Wrist Blood Pressure Monitor Model BP4350 | Omron Healthcare, Inc. | 2018 | — |
| +3 | K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2022 | — |
| +2 | K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| +4 | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NSummary page 1…Class fl Device: Model BP652N(HEM-6300-Z) Predicate Device: Oxnron - HEM-609N (HEM-6001 -Z) -K042505 Device Description: The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" b… | 2005 |
What descends from it? (21)
See all 212 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?
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. 2013, 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 device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal wit readings.
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/K123498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123498: BP652N (Hem-6300-Z).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123498
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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