# K152582: CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Dec 3, 2015 after 84 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- 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 K133641 (2013). 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)
- K133641: Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile, Volcano Corporation (2013) Summary page 4.

## Indications for use
The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures. The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.

Source page: https://510kreport.com/device/K152582
Methodology: https://510kreport.com/methodology