# K052676: KD-322 Semi Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Kodon (Tianjin)Electronic&Electrical Apparatus Co.,
- Decided: Feb 17, 2006 after 143 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K053035: Acro Biotech LLC Rapid Benzoylecgonine Urine Test; Catalog# MET001000, Acro Biotech, LLC (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K080326: KD-391 Semi Automatic Electronic Blood Pressure Monitor (2008), 2 descendants of its own
- 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 (2009), 1 descendant of its own
- K190207: Blood Pressure Monitor (2019), 0 descendants of its own
- K091739: Semi Automatic Electronic Blood Pressure Monitor, Models KD-3917, KD 3909 (2009), 0 descendants of its own
- K091738: Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BD (2009), 0 descendants of its own

## Indications for use
The KD-322 Semi 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 upper arm. The cuff circumference is limited to 8.6614 inches to 13.78 inches.

Source page: https://510kreport.com/device/K052676
Methodology: https://510kreport.com/methodology