Cleared Traditional

K954826 - DISETRONIC MULTIFUSE PUMP SYSTEM

K954826 is an FDA 510(k) clearance for DISETRONIC MULTIFUSE PUMP SYSTEM, manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K954826 · Disetronic Medical Systems · General Hospital
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May 1996
Decision
217d
Days
Class 2
Risk

K954826 is an FDA 510(k) clearance for the DISETRONIC MULTIFUSE PUMP SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Minneapolis, US). The FDA issued a Cleared decision on May 24, 1996 after a review of 217 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 Disetronic Medical Systems devices

FDA 510(k) Submission Details - K954826

510(k) Number K954826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 20, 1995
Decision Date May 24, 1996
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
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 523
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K954826.
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K955231 · Medex, Inc. · Jul 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
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
K955180 · Sims Deltec, Inc. · May 1996
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K953896 · Imed Corp. · Mar 1996
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996