Cleared Special

K990259 - DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

K990259 is an FDA 510(k) clearance for DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM, manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 16-day FDA review.

K990259 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
16d
Days
Class 2
Risk

K990259 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 (Fort Myers, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 16 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.

FDA 510(k) Submission Details - K990259

510(k) Number K990259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1999
Decision Date February 12, 1999
Days to Decision 16 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 675
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K990259.
PEREGRINE WET SET, MODEL PD400.00
K990518 · Peregrine Surgical , Ltd. · Mar 1999
PAIN CONTROL INFUSION PUMP
K990101 · Sgarlato Laboratories, Inc. · Mar 1999
SABRATEK 4040 INFUSION PUMP
K980751 · Sabratek Corp. · Feb 1999
PERFUSOR COMPACT
K983005 · B.Braun Medical, Inc. · Feb 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
VARIABLE PRESSURE SYRINGE PUMP
K974332 · Alaris Medical Systems, Inc. · Dec 1998
K990259 · DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
Download PDF FDA Summary Disetronic Medical Sy…