Cleared Traditional

K111386 - MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP

K111386 is an FDA 510(k) clearance for MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, manufactured by Smiths Medical MD, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K111386 · Smiths Medical MD, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
103d
Days
Class 2
Risk

K111386 is an FDA 510(k) clearance for the MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION S.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 29, 2011 after a review of 103 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 Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K111386

510(k) Number K111386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2011
Decision Date August 29, 2011
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
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 460
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