510(k) · Cleared
ClearedLD-578 Fully Automatic Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Little Doctor (Shanghai) Electronic · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 18, 2006 after a 102-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 102 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 2 citing it directly.
- This deviceK061279 LD-578 Fully Automatic Digital Blood Pressure MonitorLittle Doctor (Shanghai) Electronic · 2006
- Descendant · cites it directly · 0 of its ownK122810 Compact Digital Blood Pressure MonitorThermor, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK093359 1103 Digital Blood Pressure Monitor, Model LD 1103, 1133 Digital…Shanghai Little Doctor Co. Limited · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061279 | LD-578 Fully Automatic Digital Blood Pressure Monitor | Little Doctor (Shanghai) Electronic | 2006 | — |
| +1 | K122810 | Compact Digital Blood Pressure Monitor | Thermor, Ltd. | 2013 | — |
| +1 | K093359 | 1103 Digital Blood Pressure Monitor, Model LD 1103, 1133 Digital Blood… | Shanghai Little Doctor Co. Limited | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K043440 | FDA’s K043440 is Smith & Nephew, Inc. Revision Knee System Our reading of the summary gave K043440, FDA’s number for Smith & Nephew, Inc. Revision Knee System (Smith & Nephew, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AMPLIFE Upper Arm Blood Pressure Monitor, Model M100”. Kept off the family tree. Summary page 2…n to the Predicate Device: The LD-578 Fully Automatic Digital Blood Pressure and predicate device (AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, K043440) are identical in functionality and performance with the difference being the external shape of the device, dimen… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K122810 (Thermor, Ltd., 2013) 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.
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 Shanghai Little Doctor LD-578 Fully Automatic Digital Blood Pressure Monitor, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061279: LD-578 Fully Automatic Digital Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061279
Report an extraction error
Are you the manufacturer?
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