Cleared Traditional

K955231 - MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP

K955231 is an FDA 510(k) clearance for MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP, 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 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

FDA 510(k) Submission Details - K955231

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.

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 K955231.
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
K962709 · Sigma Intl. · Oct 1996
CADD-PRIZM MODEL 6100 PUMP
K960826 · Sims Deltec, Inc. · Aug 1996
MODEL 1200 ABMULATORY INFUSION PUMP
K961263 · Patient Solutions, Inc. · Aug 1996
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K961703 · Baxter Healthcare Corp · Jul 1996
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
K960957 · Sims Deltec, Inc. · Jun 1996
3030 INFUSION PUMP
K955258 · Sabratek Corp. · Jun 1996