# K243205: EVAC

- Pathway: 510(k) (Traditional)
- Applicant: Phasor Health, LLC
- Decided: Jun 3, 2025 after 245 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
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. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K193661: LightWalker Laser System Family, Fotona D.O.O. (2020). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K193542: Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22, Bellco Srl (2020). Our reading of the summary gave K193542, FDA’s number for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17… (Bellco Srl). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bioteq, Inc. The Unisor Drill”. Kept off the family tree.

## Most influential descendants
- K252514: Evac-Mri (2025), 0 descendants of its own

## Indications for use
Phasor EVAC™ is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The EVAC 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/K243205
Methodology: https://510kreport.com/methodology