Cleared Traditional

K052594 - WILLCARE

K052594 is the FDA 510(k) clearance for WILLCARE by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K052594 · Icu Medical, Inc. · General Hospital
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Feb 2006
Decision
142d
Days
Class 2
Risk

K052594 is an FDA 510(k) clearance for the WILLCARE, MODEL GW-1020. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on February 10, 2006 after a review of 142 days - within the typical 510(k) review window.

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 Icu Medical, Inc. devices

Submission Details

510(k) Number K052594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2005
Decision Date February 10, 2006
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K052594.
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K062700 · B.Braun Medical, Inc. · Oct 2006
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · Medrad, Inc. · May 2006
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087
K060806 · Hospira, Inc. · Apr 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
K052052 · Hospira, Inc. · Aug 2005

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.