# K061279: LD-578 Fully Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Little Doctor (Shanghai) Electronic
- Decided: Aug 18, 2006 after 102 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005). 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.

## Most influential descendants
- K122810: Compact Digital Blood Pressure Monitor (2013), 0 descendants of its own
- K093359: 1103 Digital Blood Pressure Monitor, Model LD 1103, 1133 Digital Blood Pressure Monitor, Model LD 1133 (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K061279
Methodology: https://510kreport.com/methodology