# K101010: Fully Automatic Electronic Blood Pressure Monitor Model: KD-5963NU, KD-5008

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 30, 2010 after 109 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K111826: Fully Automatic Electronic Blood Pressure Monitor (2011), 0 descendants of its own
- K102609: KD-5966 Series Fully Automatic Electronic Blood Pressure Monitor (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K101010
Methodology: https://510kreport.com/methodology