# K012498: Dynapulse 500G (DP500G) Bllod Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Pulse Metric, Inc.
- Decided: Nov 1, 2001 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050680: Blood Pressure Monitor with Spectrum/P2, X2, A2, and K7 (2005), 0 descendants of its own

## Indications for use
The DynaPulse 500G is indicated for trained medical professionals to operate on patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information. In addition, the DynaPulse 500G is indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K012498
Methodology: https://510kreport.com/methodology