Cleared Traditional

K002073 - PAIN CARE 3000

K002073 is an FDA 510(k) clearance for PAIN CARE 3000, manufactured by Breg, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K002073 · Breg, Inc. · General Hospital
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Sep 2000
Decision
71d
Days
Class 2
Risk

K002073 is an FDA 510(k) clearance for the PAIN CARE 3000. 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 September 19, 2000 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Breg, Inc. devices

FDA 510(k) Submission Details - K002073

510(k) Number K002073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date September 19, 2000
Days to Decision 71 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 59
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K002073.
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · I-Flow Corp. · Mar 2002
PAIN CARE 3200
K013928 · Breg, Inc. · Dec 2001
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
PAIN CARE 2000L
K002321 · Breg, Inc. · Aug 2000
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
K993832 · Tandem Medical, Inc. · Feb 2000
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000