Cleared Traditional

K051253 - MODIFICATION TO: MULTIRATE INFUSOR SV )...

K051253 is the FDA 510(k) clearance for MODIFICATION TO: MULTIRATE INFUSOR SV )... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code MEA) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K051253 · Baxter Healthcare Corp · General Hospital
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Jul 2005
Decision
60d
Days
Class 2
Risk

K051253 is an FDA 510(k) clearance for the MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUS.... Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on July 15, 2005 after a review of 60 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 K051253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date July 15, 2005
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 15
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K051253.
LifeCare PCA Infusion System
K143612 · Hospira, Inc. · Apr 2016
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · Smiths Medical Asd, Inc. · Dec 2013
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · B.Braun Medical, Inc. · Nov 2009
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256 · Hospira, Inc. · Dec 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · Hospira, Inc. · Oct 2004
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003