510(k) · Cleared
ClearedHL888SF
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 Apr 21, 2006 after a 25-day review. The FDA summary names no predicate by number. 15 later devices descend from it.
- Decided
- Apr 21, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK060835 HL888SFHealth & Life Co., Ltd. · 2006
- Descendant · cites it directly · 14 of its ownK092161 Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009
- Descendant · 2 generations on · 12 of its ownK093831 Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010
- Descendant · 3 generations on · 9 of its ownK131121 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · 2 generations on · 9 of its ownK113238 Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd. · 2012
- Descendant · 3 generations on · 8 of its ownK142968 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K092161Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009 · cites it directly14descendants
- K093831Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010 · 2 generations on12descendants
- K131121Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · 3 generations on9descendants
- K113238Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd. · 2012 · 2 generations on9descendants
- K142968Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060835 | HL888SF | Health & Life Co., Ltd. | 2006 | — |
| +1 | K092161 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF | Health & Life Co., Ltd. | 2009 | — |
| +2 | K093831 | Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT | Health & Life Co., Ltd. | 2010 | — |
| +3 | K131121 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +2 | K113238 | Full Automatic (Nibp) Blood Pressue Monitor | Health & Life Co., Ltd. | 2012 | — |
| +3 | K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092161 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF | 2009 | 14 |
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, K092161 (Health & Life Co., Ltd., 2009) has gone furthest, with 14 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.
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?
Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method, All values can be read out in one LCD panel The intended use of this over-the-counter-deviCe is for the over age of 18,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060835 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060835: HL888SF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060835
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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