510(k) · Cleared
ClearedFull Automatic (NIBP) Blood Pressure Monitor-HL158UB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 13, 2019 as substantially equivalent to K162338 (Health & Life Co., Ltd., 2016) after a 136-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Jun 13, 2019
- Review
- 136 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042505 (2005). 7 ancestors in all, the oldest K003732 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 4 generations backK123498 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013
- 3 generations backK142917 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014
- 2 generations backK160557 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- 1 generation backK162338 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- This deviceK190133 Full Automatic (NIBP) Blood Pressure Monitor-HL158UBHealth & Life Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −4 | K123498 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2013 | — |
| −3 | K142917 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2014 | — |
| −2 | K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| −1 | K162338 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| 0 (this device) | K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Health & Life Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K162338 | Full Automatic (NIBP) Blood Pressure MonitorSummary page 4…iovascular Product Code: DXN 3. Information for the 510(k) Cleared Device (Predicate Device): Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158UA (K162338) 4. Device Description: HL158UB automatically measures human’s Systolic, Diastolic blood pressure and heart rate by… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K162338.
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. 2019, 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?
HL158UB automatically measures human’s Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being’s wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use. HL158UB detects the…
Read the full statement (110 words)
HL158UB automatically measures human’s Systolic, Diastolic blood pressure and heart rate by using the oscillometric
method during inflation. All values can be read out in one LCD panel. Measurement position is at human being’s wrist.
The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging
from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.
HL158UB detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with
measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user
tracking their blood pressure level.
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/K190133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190133: Full Automatic (NIBP) Blood Pressure Monitor-HL158UB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190133
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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