Cleared Special

K192802 - primeMidline Catheters (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192802 · Pfm Medical, Inc. · General Hospital
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Oct 2019
Decision
28d
Days
Class 2
Risk

K192802 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 October 28, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pfm Medical, Inc. devices

Submission Details

510(k) Number K192802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date October 28, 2019
Days to Decision 28 days
Submission Type Special
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
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - PND Midline Catheter

All 12
Devices cleared under the same product code (PND) and FDA review panel - the closest regulatory comparables to K192802.
Midline Catheter
K252402 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Arrow Pressure Injectable Midline Catheter
K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · Sep 2022
Provena(TM) Midline Catheter
K213203 · C.R. Bard, Inc. · May 2022
Stiletto Extended Dwell Catheter
K210047 · Piper Access, LLC · Aug 2021