510(k) · Cleared
ClearedFull Automatic (NIBP) Blood Pressure Monitor
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 Mar 29, 2016 as substantially equivalent to K093824 (Health & Life Co., Ltd., 2010) after a 50-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- Mar 29, 2016
- Review
- 50 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093824 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK093824 Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BTHealth & Life Co., Ltd. · 2010
- This deviceK160336 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK190134 Full Automatic (NIBP) Blood Pressure Monitor-HL158TBHealth & Life Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TBHealth & Life Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093824 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT | Health & Life Co., Ltd. | 2010 | — |
| 0 (this device) | K160336 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| +1 | K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | Health & Life Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K093824 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BTSummary page 5…Page 2 of 6 3. Information for the 510(k) Cleared Device (Predicate Device): Full Automatic (NIBP) Blood Pressure Monitor, Model: HL158BT (K093824) 4. Device Description: HL158TA automatically measures human’s Systolic, Diastolic blood pressure and heart rate by usin… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | 2019 | 0 |
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. 2016, 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?
HL158TA 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.
HL158TA 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 as stated in the FDA summary.
https://510kreport.com/device/K160336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160336: Full Automatic (NIBP) 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/K160336
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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