Cleared Special

K003611 - PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003611 · Breg, Inc. · General Hospital
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.

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
Regulatory Context
Review time vs. panel average
148d faster than avg
Panel avg: 169d · 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 15
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K003611.
FreedomEdge Infusion System
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K242114 · Icu Medical, Inc. · Apr 2025