Cleared Traditional

K042432 - PHARMGUARD TOOLBOX, MODEL G6000782

K042432 is an FDA 510(k) clearance for PHARMGUARD TOOLBOX, manufactured by Medex, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K042432 · Medex, Inc. · General Hospital
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Jan 2005
Decision
118d
Days
Class 2
Risk

K042432 is an FDA 510(k) clearance for the PHARMGUARD TOOLBOX, MODEL G6000782. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medex, Inc. (Dublin, US). The FDA issued a Cleared decision on January 4, 2005 after a review of 118 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Medex, Inc. devices

FDA 510(k) Submission Details - K042432

510(k) Number K042432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2004
Decision Date January 04, 2005
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
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 587
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K042432.
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
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
K042980 · Hospira, Inc. · Nov 2004
BEELINE MOTIV, PROPOLIS, PCA
K042228 · Mckinley, Inc. · Nov 2004