Cleared Special

K003611 - PAIN CARE MULTI-PORT CATHETER

K003611 is the FDA 510(k) clearance for PAIN CARE MULTI-PORT CATHETER by Breg, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Special 510(k) pathway after a 21-day FDA review.

K003611 · Breg, Inc. · General Hospital
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Dec 2000
Decision
21d
Days
Class 2
Risk

K003611 is an FDA 510(k) clearance for the PAIN CARE MULTI-PORT CATHETER, MODEL 2000L. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on December 13, 2000 after a review of 21 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 Breg, Inc. devices

Submission Details

510(k) Number K003611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2000
Decision Date December 13, 2000
Days to Decision 21 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 434
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K003611.
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp · May 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · Abbott Laboratories · May 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · Abbott Laboratories · Apr 2001
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · Baxter Healthcare Corp · Dec 2000
INFUSOMAT P
K003029 · B.Braun Medical, Inc. · Dec 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · Baxter Healthcare Corp · Sep 2000