Cleared Traditional

K955231 - MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP

K955231 is the FDA 510(k) clearance for MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP by Medex, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K955231 · Medex, Inc. · General Hospital
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Jul 1996
Decision
247d
Days
Class 2
Risk

K955231 is an FDA 510(k) clearance for the MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medex, Inc. (Duluth, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 247 days - an extended review 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: 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

Submission Details

510(k) Number K955231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received November 14, 1995
Decision Date July 18, 1996
Days to Decision 247 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
118d slower than avg
Panel avg: 129d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K955231.
PULSE*SPRAY INJECTOR
K963574 · AngioDynamics, Inc. · Jul 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · Bio-Tek Instruments, Inc. · Feb 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K961703 · Baxter Healthcare Corp · Jul 1996
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K953896 · Imed Corp. · Mar 1996
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996