Cleared Traditional

K180792 - Arterial Pressure Monitoring Set/Tray

K180792 is the FDA 510(k) clearance for Arterial Pressure Monitoring Set/Tray by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K180792 · Cook Incorporated · Cardiovascular device
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Nov 2018
Decision
248d
Days
Class 2
Risk

K180792 is an FDA 510(k) clearance for the Arterial Pressure Monitoring Set/Tray. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on November 30, 2018 after a review of 248 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

Submission Details

510(k) Number K180792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2018
Decision Date November 30, 2018
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 290
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K180792.
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K181722 · Cook Incorporated · Mar 2019
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K181836 · Cordis, A Cardinal Health Company · Aug 2018