510(k) · Cleared
ClearedThe Wrist-Type Fully Automatic Digital Blood Pressure Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joytech Healthcare Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 22, 2017 as substantially equivalent to K121355 (Sejoy Electronics & Instruments Co., Ltd., 2012) after a 261-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Nov 22, 2017
- Review
- 261 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002115 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
- 3 generations backK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
- 2 generations backK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
- 1 generation backK121355 Wrist-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2012
- This deviceK170666 The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsJoytech Healthcare Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2000 | — |
| −3 | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328 | A&D Engineering, Inc. | 2004 | — |
| −2 | K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512 | A&D Engineering, Inc. | 2004 | — |
| −1 | K121355 | Wrist-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2012 | — |
| 0 (this device) | K170666 | The Wrist-Type Fully Automatic Digital Blood Pressure Monitors | Joytech Healthcare Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K121355 | Wrist-Type Fully Automatic Digital Blood Pressure MonitorSummary page 4…Information: The Wrist-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the Predicate device of Sejoy, BP-2208 (K Number: K121355). 2.6. Device Description: The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrappi… | 2012 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K121355.
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. 2017, 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?
The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170666: The Wrist-Type Fully Automatic Digital Blood Pressure Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170666
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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