Blood Administration Sets

by Baxter Healthcare Corporation 510(k)

Active United States

510(k) K220558

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK220558	Date17 Nov 2022Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

510(k)

510(k) Number: K220558
FDA Product Code: BRZ

Device Class: Class II
Regulation: 21 CFR Part 880.5440
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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