Cleared Traditional

K230041 - Spectrum IQ Infusion System with Dose IQ Safety Software

K230041 is an FDA 510(k) clearance for Spectrum IQ Infusion System with Dose I..., manufactured by Baxter Healthcare Corporation. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K230041 · Baxter Healthcare Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
84d
Days
Class 2
Risk

K230041 is an FDA 510(k) clearance for the Spectrum IQ Infusion System with Dose IQ Safety Software. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on March 31, 2023 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corporation devices

FDA 510(k) Submission Details - K230041

510(k) Number K230041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2023
Decision Date March 31, 2023
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K230041.
Plum Duo™ Infusion System
K223607 · Icu Medical, Inc. · Aug 2023
BD Alaris System with Guardrails Suite MX v12.1.2
K211218 · Carefusion 303, Inc. · Jul 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · Baxter Healthcare Corporation · Mar 2023
Avoset Infusion Pump System
K213744 · Eitan Medical , Ltd. · Mar 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · Baxter Healthcare Corporation · Sep 2022
Novum IQ Syringe Pump
K211125 · Baxter Healthcare Corporation · Aug 2022