Cleared Traditional

K050324 - INFPUMP INFILTRATION PUMP

K050324 is an FDA 510(k) clearance for INFPUMP INFILTRATION PUMP, manufactured by Carolina Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K050324 · Carolina Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
77d
Days
Class 2
Risk

K050324 is an FDA 510(k) clearance for the INFPUMP INFILTRATION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Carolina Medical, Inc. (King, US). The FDA issued a Cleared decision on April 27, 2005 after a review of 77 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.

FDA 510(k) Submission Details - K050324

510(k) Number K050324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date April 27, 2005
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 761
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K050324.
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K050324 · INFPUMP INFILTRATION PUMP
Download PDF FDA Summary Carolina Medical, Inc.