Cleared Special

K001629 - DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

K001629 is an FDA 510(k) clearance for DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM, manufactured by Disetronic Medical Systems AG. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 26-day FDA review.

K001629 · Disetronic Medical Systems AG · General Hospital
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Jun 2000
Decision
26d
Days
Class 2
Risk

K001629 is an FDA 510(k) clearance for the DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (Fort Myers, US). The FDA issued a Cleared decision on June 21, 2000 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Disetronic Medical Systems AG devices

FDA 510(k) Submission Details - K001629

510(k) Number K001629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2000
Decision Date June 21, 2000
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 531
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K001629.
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
K993524 · Alaris Medical Systems, Inc. · Aug 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
K002211 · Baxter Healthcare Corp · Jul 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · Abbott Laboratories · Jul 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · Sims Deltec, Inc. · Jun 2000
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K994274 · Quest Medical, Inc. · May 2000
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
K000328 · Medex, Inc. · May 2000