Cleared Traditional

K230665 - Dose IQ Safety Software (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230665 · Baxter Healthcare Corporation · General Hospital
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Mar 2024
Decision
385d
Days
Class 2
Risk

K230665 is an FDA 510(k) clearance for the Dose IQ Safety Software. Classified as Infusion Safety Management Software (product code PHC), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on March 29, 2024 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corporation devices

Submission Details

510(k) Number K230665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2023
Decision Date March 29, 2024
Days to Decision 385 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 128d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHC Infusion Safety Management Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - PHC Infusion Safety Management Software

All 9
Devices cleared under the same product code (PHC) and FDA review panel - the closest regulatory comparables to K230665.
LifeShield Infusion Safety Software Suite
K252130 · Icu Medical, Inc. · Apr 2026
BD Intelliport System
K243062 · Becton Dickinson · Jun 2025
LifeShield Infusion Safety Software Suite
K242117 · Icu Medical, Inc. · Apr 2025
LifeShield™ Infusion Safety Software Suite
K223606 · Icu Medical, Inc. · Aug 2023
Dose IQ Safety Software
K211124 · Baxter Healthcare Corporation · Aug 2022