Spectrum IQ Infusion System with Dose IQ Safety Software

by Baxter Healthcare Corporation 3 variants

510(k) K220417

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 24 Oct 2026

Documents

510(k) K220417↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK220417	Date29 Apr 2022Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K220417
FDA Product Code: FRN

Device Class: Class II
Regulation: 21 CFR Part 880.5725
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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