Cleared Traditional

K043590 - SE INFUSION SYSTEM WITH MMS

K043590 is an FDA 510(k) clearance for SE INFUSION SYSTEM WITH MMS, manufactured by Cardinal Health, Alaris Products. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K043590 · Cardinal Health, Alaris Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
87d
Days
Class 2
Risk

K043590 is an FDA 510(k) clearance for the SE INFUSION SYSTEM WITH MMS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardinal Health, Alaris Products (San Diego, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 87 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 Cardinal Health, Alaris Products devices

FDA 510(k) Submission Details - K043590

510(k) Number K043590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2004
Decision Date March 25, 2005
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 635
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K043590.
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
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SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
K043204 · Sgarlato Laboratories, Inc. · Mar 2005
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · Medtronic Minimed · Mar 2005
MRIDIUM 3850 MRI PUMP SYSTEM
K050301 · Iradimed Corporation · Mar 2005
BODYGUARD INFUSION PUMP SYSTEM
K042696 · Caesarea Medical Electronics , Ltd. · Mar 2005
HARVARD 2 SYRINGE PUMP, MODEL 2001-001
K050107 · Harvard Clinical Technology · Feb 2005