# K173114: primeMidline Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Mar 7, 2018 after 159 days
- Product code: PND (Midline Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153393: PowerMidline Catheter, C.R. Bard, Inc. (2016) Summary page 4.

## Most influential descendants
- K192802: primeMidline Catheters (2019), 0 descendants of its own

## Indications for use
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

Source page: https://510kreport.com/device/K173114
Methodology: https://510kreport.com/methodology