Cleared Special

K013928 - PAIN CARE 3200 (FDA 510(k) Clearance)

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

K013928 · Breg, Inc. · General Hospital
Dec 2001
Decision
5d
Days
Class 2
Risk

K013928 is an FDA 510(k) clearance for the PAIN CARE 3200. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 5 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 K013928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2001
Decision Date December 03, 2001
Days to Decision 5 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Regulatory Context
Review time vs. panel average
164d faster than avg
Panel avg: 169d · This submission: 5d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
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.