510(k) · Cleared
ClearedFull Automatic (Nibp) Blood Pressure Monitor, Model HL888V, Full Automatic (Nibp) Blood Pressure Monitor, Model HL868JM
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 Jan 22, 2010 as substantially equivalent to K032837 (Health & Life Co., Ltd., 2003) after a 39-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jan 22, 2010
- Review
- 39 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032837 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK032837 HL888BMHealth & Life Co., Ltd. · 2003
- This deviceK093823 Full Automatic (Nibp) Blood Pressure Monitor, Model HL888V, Full…Health & Life Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032837 | HL888BM | Health & Life Co., Ltd. | 2003 | — |
| 0 (this device) | K093823 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL888V, Full Automatic… | Health & Life Co., Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K032837 | HL888BMSummary page 1…Code: DXN Panel: Cardiovascular 3. Information for the 510(k) Cleared Device (Predicate Device): H&L Full Automatic (NIBP) Blood Pressure Monitor, Model HL888BM, K032837 4. Device Description: Both HL888V and HL868JM are manual inflate type blood pressure monitors for measurement of human'… | 2003 |
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
HL888V is a manual inflate type blood pressure monitor for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9-.13 inches (approx.23cm-33cm). HL868JM is a manual inflate type blood pressure monitor for…
Read the full statement (125 words)
HL888V is a manual inflate type blood pressure monitor for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9-.13 inches (approx.23cm-33cm).
HL868JM is a manual inflate type blood pressure monitor for measurement of human's Systolic; Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper ann. It is recommended for use by adults aged 18 years and older with arm cicumference rangin 9-.-13 inches (approx.23cm-3 3cm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093823: Full Automatic (Nibp) Blood Pressure Monitor, Model HL888V, Full Automatic (Nibp) Blood Pressure Monitor, Model HL868JM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093823
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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