# K011310: Nien Made Non-Invasive Blood  Pressure Monitor, Models HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1

- Pathway: 510(k) (Abbreviated)
- Applicant: Nien Made Electrnics Corp.
- Decided: Jul 20, 2001 after 81 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

Source page: https://510kreport.com/device/K011310
Methodology: https://510kreport.com/methodology