# K252514: Evac-Mri

- Pathway: 510(k) (Traditional)
- Applicant: Phasor Health, LLC
- Decided: Nov 5, 2025 after 86 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915546 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243205: EVAC, Phasor Health, LLC (2025) Summary page 5.
- K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal, Medical Designs, LLC (2004) Summary page 5.
- K961113: CNS Interchangeable Bit Cranial Drill, Clinical Neuro Systems, LLC (1996) Summary page 5.

## Indications for use
Phasor EVAC-MRI is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Phasor EVAC-MRI system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Phasor EVAC–MRI system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Source page: https://510kreport.com/device/K252514
Methodology: https://510kreport.com/methodology