Cleared Traditional

K173114 - primeMidline Catheters (FDA 510(k) Clearance)

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

K173114 · Pfm Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
159d
Days
Class 2
Risk

K173114 is an FDA 510(k) clearance for the primeMidline Catheters. Classified as Midline Catheter (product code PND), Class II - Special Controls.

Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 7, 2018 after a review of 159 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 Pfm Medical, Inc. devices

Submission Details

510(k) Number K173114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date March 07, 2018
Days to Decision 159 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
31d slower than avg
Panel avg: 128d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PND Midline Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
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.