Cleared Special

K002321 - PAIN CARE 2000L

K002321 is an FDA 510(k) clearance for PAIN CARE 2000L, manufactured by Breg, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 14-day FDA review.

K002321 · Breg, Inc. · General Hospital
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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.

View all Breg, Inc. devices

FDA 510(k) Submission Details - K002321

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

MEB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 41
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K002321.
PAIN CARE 3200
K013928 · Breg, Inc. · Dec 2001
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
PAIN CARE 3000
K002073 · Breg, Inc. · Sep 2000
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000
INTRAOP CATHETER
K991543 · I-Flow Corp. · Oct 1999
NERVE BLOCK INFUSION KIT
K984502 · I-Flow Corp. · Mar 1999