510(k) · Cleared
ClearedDigital Wrist Blood Pressure Monitor, Model LD 1143
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Little Doctor Co. Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 25, 2009 as substantially equivalent to K070825 (Little Doctor (Shanghai) Electronic Manufacturing, 2007) after a 24-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Sep 25, 2009
- Review
- 24 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002115 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
- 2 generations backK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
- 1 generation backK070825 LD8 Digital Wrist Blood Pressure MonitorLittle Doctor (Shanghai) Electronic Manufacturing · 2007
- This deviceK092683 Digital Wrist Blood Pressure Monitor, Model LD 1143Shanghai Little Doctor Co. Limited · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2000 | — |
| −2 | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328 | A&D Engineering, Inc. | 2004 | — |
| −1 | K070825 | LD8 Digital Wrist Blood Pressure Monitor | Little Doctor (Shanghai) Electronic Manufacturing | 2007 | — |
| 0 (this device) | K092683 | Digital Wrist Blood Pressure Monitor, Model LD 1143 | Shanghai Little Doctor Co. Limited | 2009 | — |
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 510(k) statement (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 |
|---|---|---|---|
| * | K070825 | LD8 Digital Wrist Blood Pressure MonitorSummary page 2…4--2 C. Identification of FDA Cleared Devices(predicate) 1. Name: Digital wrist blood pressure monitor, model LD 8 2. K Number: K070825 3. Date Cleared: May 25, 2007 D. Description of the Device The Digital Wrist Blood Pressure Monitor, Model LD1143, is designed to… | 2007 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a 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. 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?
The subject is intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092683 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092683: Digital Wrist Blood Pressure Monitor, Model LD 1143.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092683
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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