Cleared Traditional

K120008 - MEDLINE HIGH PRESSURE INJECTION TUBING

K120008 is the FDA 510(k) clearance for MEDLINE HIGH PRESSURE INJECTION TUBING by Medline Industries, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K120008 · Medline Industries, Inc. · Cardiovascular device
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Aug 2012
Decision
227d
Days
Class 2
Risk

K120008 is an FDA 510(k) clearance for the MEDLINE HIGH PRESSURE INJECTION TUBING. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 227 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K120008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date August 17, 2012
Days to Decision 227 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 125d · This submission: 227d
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 247
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