# K053185: Primo Noninvasive Blood Pressure Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Medwave, Inc.
- Decided: Jan 24, 2006 after 71 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: 1 generation back to K001898 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001898: Vasotrax, Medwave, Inc. (2000) Summary page 1.

## Indications for use
The PrimoTM Noninvasive Blood Pressure Measurement System is a hand held non-invasive blood pressure measurement system intended to be used on adult patients with wrist circumferences of 11 cm - 22 cm by trained medical personnel to measure systolic and diastolic blood pressure and pulse rate.

Source page: https://510kreport.com/device/K053185
Methodology: https://510kreport.com/methodology