510(k) · Cleared
ClearedFull Automatic (Nibp) Blood Pressure Monitor, Model HL158BT
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 Feb 16, 2010 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Feb 16, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK093824 Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BTHealth & Life Co., Ltd. · 2010
- Descendant · cites it directly · 6 of its ownK130564 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK160557 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK151281 AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK193628 AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK162338 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K130564Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · cites it directly6descendants
- K160557Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016 · cites it directly3descendants
- K151281AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015 · 2 generations on3descendants
- K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020 · 3 generations on2descendants
- K162338Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093824 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT | Health & Life Co., Ltd. | 2010 | — |
| +1 | K130564 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +1 | K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| +2 | K151281 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan Ageless Health Industrial Co., Ltd. | 2015 | — |
| +3 | K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020 | — |
| +2 | K162338 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 133 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?
- Of its descendants, K130564 (Health & Life Co., Ltd., 2013) has gone furthest, with 6 descendants of its own.
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. 2010, 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 | — |
https://510kreport.com/device/K093824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093824: Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093824
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026