Cleared Traditional

K853814 - MP0400 ADULT, PERISTALIC INFUSION PUMP

K853814 is an FDA 510(k) clearance for MP0400 ADULT, 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 126-day FDA review.

K853814 · Medex, Inc. · General Hospital
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Jan 1986
Decision
126d
Days
Class 2
Risk

K853814 is an FDA 510(k) clearance for the MP0400 ADULT, PERISTALIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on January 16, 1986 after a review of 126 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.

FDA 510(k) Submission Details - K853814

510(k) Number K853814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1985
Decision Date January 16, 1986
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
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 848
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K853814.
NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE
K860492 · Nordisk Infuser System · Feb 1986
PMT ACCUPRESSURE INFUSION SYSTEM 3601
K854157 · Progress Mankind Technology · Feb 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986
MODEL 210 INFUSION PUMP
K854073 · Avi, Inc. · Dec 1985
MODEL 200 INFUSION PUMP
K854074 · Avi, Inc. · Dec 1985
FLUID MANAGEMENT SYSTEM
K852645 · Haemonetics Corp. · Dec 1985
K853814 · MP0400 ADULT, PERISTALIC INFUSION PUMP
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