Cleared Special

K170770 - CT Midline (FDA 510(k) Clearance)

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

K170770 · Medical Components, Inc. (dba MedComp) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
133d
Days
Class 2
Risk

K170770 is an FDA 510(k) clearance for the CT Midline. Classified as Midline Catheter (product code PND), Class II - Special Controls.

Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on July 25, 2017 after a review of 133 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Components, Inc. (dba MedComp) devices

Submission Details

510(k) Number K170770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2017
Decision Date July 25, 2017
Days to Decision 133 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 128d · This submission: 133d
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 K170770.
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