# K083395: Semi-Fully Automatic Electronic Blood Pressure Monitor, Models: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Feb 27, 2009 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
Longest line of descent: 3 generations back to K001670 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052676: KD-322 Semi Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2006) Summary page 1.
- K030358: KD-622 Fully Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2003) Summary page 1.
- K070395: KD-525E Fully Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.
- K042418: KD-575 Memory Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2005) Summary page 1.
- K070828: KD-595 Fully Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.

## Most influential descendants
- K091738: Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BD (2009), 0 descendants of its own

## Indications for use
Arm Electronic Blood Pressure Monitor (Model KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) 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 upper arm. The cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).

Source page: https://510kreport.com/device/K083395
Methodology: https://510kreport.com/methodology