Cleared Traditional

K021274 - PAIN-MATE PAIN MANAGEMENT SYSTEM WITH D...

K021274 is the FDA 510(k) clearance for PAIN-MATE PAIN MANAGEMENT SYSTEM WITH D... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code MEB) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K021274 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
25d
Days
Class 2
Risk

K021274 is an FDA 510(k) clearance for the PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 17, 2002 after a review of 25 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K021274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2002
Decision Date May 17, 2002
Days to Decision 25 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 32
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K021274.
B. BRAUN NERVE BLOCK CATHETER
K030830 · B.Braun Medical, Inc. · Jul 2003
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · I-Flow Corp. · Dec 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318 · I-Flow Corp. · Oct 2002
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