Cleared Traditional

K051253 - MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)

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

K051253 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K051253

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.

MEA Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K051253.
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