# K013478: Dynapulse 5200A Pathway Blood Pressure Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Pulse Metric, Inc.
- Decided: Jan 10, 2002 after 83 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DP5200A Pathway is indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. 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/K013478
Methodology: https://510kreport.com/methodology