# K192802: primeMidline Catheters

- Pathway: 510(k) (Special)
- Applicant: Pfm Medical, Inc.
- Decided: Oct 28, 2019 after 28 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: 12 generations back to K001901 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
2 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173114: primeMidline Catheters, Pfm Medical, Inc. (2018) Summary page 4.

## 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 10 kg, 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/K192802
Methodology: https://510kreport.com/methodology