Cleared Traditional

K080007 - GRADUATED ADAPTER WITH CLAVE

K080007 is an FDA 510(k) clearance for GRADUATED ADAPTER WITH CLAVE, manufactured by Icu Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K080007 · Icu Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
132d
Days
Class 2
Risk

K080007 is an FDA 510(k) clearance for the GRADUATED ADAPTER WITH CLAVE. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 13, 2008 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080007

510(k) Number K080007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2008
Decision Date May 13, 2008
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 131d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 87
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K080007.
SELF CATH CATHETER
K100878 · Coloplast Manufacturing Us, LLC · May 2010
AMSURE PVC INTERMITTENT CATHETER
K091306 · Amsino International, Inc. · Aug 2009
FOOTPRINT URINARY DRAINAGE CATHETER
K090576 · Footprint Medical · Aug 2009
NEOMED URINARY CATHETER
K072997 · Neomed, Inc. · Dec 2007
CURE CATHETER
K072539 · Cure Medical, LLC · Sep 2007
EXPRESSWAY INTERMITTENT CATHETER
K061766 · Percutaneous Systems, Incorporated · Mar 2007
K080007 · GRADUATED ADAPTER WITH CLAVE
Download PDF FDA Summary Icu Medical, Inc.