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Phasor Evac-MRI

by Phasor Health, LLC

Phasor Evac-MRI is a Class II device made by Phasor Health, LLC, cleared under FDA 510(k) K252514 on 5 Nov 2025 and listed in FDA GUDID since 24 Nov 2025 (UDI-DI B775EVACMRI0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K252514

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB775EVACMRI0 UDI-DI Date24 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESD from GUDID Substantially Equivalent — Deferred · Traditional NumberK252514 Date5 Nov 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252514 decided 5 Nov 2025 Active
  • FDA GUDID UDI-DI B775EVACMRI0 listed 24 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252514
  2. Listed FDA GUDID B775EVACMRI0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phasor
Generic name
Cerebrospinal fluid external drainage kit
Model / reference
EVAC-MRI
Primary DI / UDI-DI
B775EVACMRI0
510(k) Number
FDA product code
JXG
GMDN term
Cerebrospinal fluid external drainage kit
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Combination product
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)