510(k) · Cleared
Recalled · 2010Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KB
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 Nov 16, 2009 as substantially equivalent to K060729 (Health & Life Co., Ltd., 2006) and 2 other predicates after a 123-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 16, 2009
- Review
- 123 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K850316 (1985). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 4 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 3 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 2 generations backK071384 Modification to: Digital Blood Pressure Monitor, Model 1901Nihon Seimitsu Sokki Co., Ltd. · 2007
- 1 generation backK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- This deviceK092163 Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KBHealth & Life Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK113239 Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF)Health & Life Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113239Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF)Health & Life Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −4 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −3 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −2 | K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007 | — |
| −1 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| 0 (this device) | K092163 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KB | Health & Life Co., Ltd. | 2009 | — |
| +1 | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K060729 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL168FVSummary page 1…ct Code: DXN Panel: Cardiovascular 3. Information for the 510(k) Cleared Device (Predicate Device): A. Full Automatic (NIP) Blood Pressure Monitor, Model HLl68FV, K060729 -B. Digital Wrist Blood Pressure Monitor, Model HEM-609N,-K042505 C. Wrist Blood Pressure monitor, Model WS-1 100, K(080177… | 2006 |
| * | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NSummary page 1…) Cleared Device (Predicate Device): A. Full Automatic (NIP) Blood Pressure Monitor, Model HLl68FV, K060729 -B. Digital Wrist Blood Pressure Monitor, Model HEM-609N,-K042505 C. Wrist Blood Pressure monitor, Model WS-1 100, K(080177 4. Device Description: HL168KB automatically measures human's Sys… | 2005 |
| * | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVSummary page 1…P) Blood Pressure Monitor, Model HLl68FV, K060729 -B. Digital Wrist Blood Pressure Monitor, Model HEM-609N,-K042505 C. Wrist Blood Pressure monitor, Model WS-1 100, K(080177 4. Device Description: HL168KB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using th… | 2008 |
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 |
|---|---|---|---|
| K113239 | Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF) | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2010 | Not classified | Z-2578-2011 | Software design | When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K113239 (Health & Life Co., Ltd., 2012) has gone furthest, with 0 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. 2009, 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?
HL168KB 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 over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3-7.7 inches) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the storage data be transferred to the connected personal computer (PC) via USB cable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092163: Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092163
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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