Cleared Traditional

K182252 - Cook Unimpregnated Central Venous Catheter

K182252 is the FDA 510(k) clearance for Cook Unimpregnated Central Venous Catheter by Cook Incorporated. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K182252 · Cook Incorporated · General Hospital
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May 2019
Decision
270d
Days
Class 2
Risk

K182252 is an FDA 510(k) clearance for the Cook Unimpregnated Central Venous Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 17, 2019 after a review of 270 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Cook Incorporated devices

Submission Details

510(k) Number K182252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2018
Decision Date May 17, 2019
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K182252.
BD Acute Central Line
K190855 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Nov 2019
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K190001 · Togo Medikit Co., Ltd. · Sep 2019
AccuCath Ace Intravascular Catheter
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BD Nexiva Closed IV Catheter System
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Introcan Safety 3 Closed IV Catheter
K182870 · B.Braun Medical, Inc. · Mar 2019
Merit RadialFlo Arterial Catheter
K182538 · Merit Medical Singapore Pte. , Ltd. · Jan 2019