Cleared Traditional

K052817 - EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF

K052817 is an FDA 510(k) clearance for EUREKA INFUSION PUMP, manufactured by Universal Medical Technologies. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K052817 · Universal Medical Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
195d
Days
Class 2
Risk

K052817 is an FDA 510(k) clearance for the EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Universal Medical Technologies (Larkspur, US). The FDA issued a Cleared decision on April 17, 2006 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Universal Medical Technologies devices

FDA 510(k) Submission Details - K052817

510(k) Number K052817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date April 17, 2006
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 548
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K052817.
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K060806 · Hospira, Inc. · Apr 2006
WILLCARE, MODEL GW-1020
K052594 · Icu Medical, Inc. · Feb 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
CADD-MS 3 AMBULATORY INFUSION PUMP
K051568 · Smiths Medical MD, Inc. · Nov 2005