Cleared Traditional

K211124 - 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.

K211124 · Baxter Healthcare Corporation · General Hospital
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Aug 2022
Decision
502d
Days
Class 2
Risk

K211124 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 August 30, 2022 after a review of 502 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Baxter Healthcare Corporation devices

Submission Details

510(k) Number K211124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2021
Decision Date August 30, 2022
Days to Decision 502 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
374d slower than avg
Panel avg: 128d · This submission: 502d
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 K211124.
LifeShield Infusion Safety Software Suite
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K243062 · Becton Dickinson · Jun 2025
LifeShield Infusion Safety Software Suite
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Dose IQ Safety Software
K230665 · Baxter Healthcare Corporation · Mar 2024
LifeShield™ Infusion Safety Software Suite
K223606 · Icu Medical, Inc. · Aug 2023