# K092510: Fully Automatic Electronic Blood Pressure Monitor, Models KD-7901, KD-7905, KD-7911

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Dec 23, 2009 after 128 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
Longest line of descent: 3 generations back to K001671 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.

## Indications for use
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm- 25cm.

Source page: https://510kreport.com/device/K092510
Methodology: https://510kreport.com/methodology