510(k) · Cleared
ClearedFull Automatic (Nibp) Blood Pressure Monitor (Model HL168KF)
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 16, 2012 as substantially equivalent to K092163 (Health & Life Co., Ltd., 2009) and 1 other predicate after a 135-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Mar 16, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K850316 (1985). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 5 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 4 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 3 generations backK071384 Modification to: Digital Blood Pressure Monitor, Model 1901Nihon Seimitsu Sokki Co., Ltd. · 2007
- 2 generations backK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- 1 generation backK092163 Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KBHealth & Life Co., Ltd. · 2009 · Recalled
- This deviceK113239 Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF)Health & Life Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −5 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −4 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −3 | K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007 | — |
| −2 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −1 | K092163 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KB | Health & Life Co., Ltd. | 2009 | 1 |
| 0 (this device) | K113239 | Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF) | Health & Life Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K092163 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KBSummary page 1…t Code: DXN Panel: Cardiovascular 3. Information for the 510(k) Cleared Device (Predicate Device): A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB, K092 163 B. A&D Digital Blood Pressure Monitor, Model UA-767PBT, K043217 4. Device Description: HL168KF uses the oscillometric metho… | 2009 |
| * | K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorSummary page 1…Cleared Device (Predicate Device): A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL168KB, K092 163 B. A&D Digital Blood Pressure Monitor, Model UA-767PBT, K043217 4. Device Description: HL168KF uses the oscillometric method to automatically measure systolic and diastolic blood pressure… | 2005 |
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 27 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
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. 2012, 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?
HL168KF automatically measures 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 wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(1 3.5 cm to 19.5 cm) and for home use. When the device detects the appearance of…
Read the full statement (111 words)
HL168KF automatically measures 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 wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(1 3.5 cm to 19.5 cm) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. Besides, HL168KF features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113239: Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113239
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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