Cleared Special

K002321 - PAIN CARE 2000L (FDA 510(k) Clearance)

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

K002321 · Breg, Inc. · General Hospital
Aug 2000
Decision
14d
Days
Class 2
Risk

K002321 is an FDA 510(k) clearance for the PAIN CARE 2000L. 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 August 14, 2000 after a review of 14 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 K002321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2000
Decision Date August 14, 2000
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Regulatory Context
Review time vs. panel average
155d faster than avg
Panel avg: 169d · This submission: 14d
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.