Cleared Traditional

K003476 - MPS ACACIA PAIN KIT

K003476 is an FDA 510(k) clearance for MPS ACACIA PAIN KIT, manufactured by Mps Acacia. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K003476 · Mps Acacia · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
64d
Days
Class 2
Risk

K003476 is an FDA 510(k) clearance for the MPS ACACIA PAIN KIT. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Mps Acacia (Brea, US). The FDA issued a Cleared decision on January 12, 2001 after a review of 64 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 Mps Acacia devices

FDA 510(k) Submission Details - K003476

510(k) Number K003476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2000
Decision Date January 12, 2001
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
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 34
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K003476.
I-FLOW ELASTOMERIC PUMP
K020862 · I-Flow Corp. · Mar 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · I-Flow Corp. · Mar 2002
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
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