Cleared Traditional

K171954 - ClearLine IV (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171954 · Clearline MD · General Hospital
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Jan 2018
Decision
210d
Days
Class 2
Risk

K171954 is an FDA 510(k) clearance for the ClearLine IV. Classified as Intravascular Administration Set, Automated Air Removal System (product code OKL), Class II - Special Controls.

Submitted by Clearline MD (Woburn, US). The FDA issued a Cleared decision on January 25, 2018 after a review of 210 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5445 - 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.

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Submission Details

510(k) Number K171954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2017
Decision Date January 25, 2018
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 128d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OKL Intravascular Administration Set, Automated Air Removal System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5445
Definition An Intravascular Administration Set, Automated Air Removal System Is A Prescription Device Used To Detect And Automatically Remove Air From An Intravascular Administration Set With Minimal To No Interruption In The Flow Of The Iv Fluid.
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.