# K161866: BioFlo Midline Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Navilyst Medical, Inc.
- Decided: Sep 8, 2016 after 63 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K932323 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150407: BioFlo Midline Catheter, Navilyst Medical, Inc. (2015) Summary page 4.

## Recalls of this device
- May 10, 2018 · Class II · Z-2202-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2199-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2198-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

## Indications for use
The BioFlo Midline catheter is indicated for short term access to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Maximum Power Injection Flow Rate * 3F Single Lumen/20 cm - 2 mL/sec * 4F Single Lumen/20 cm - 6 mlL/sec * 5F Single Lumen/20 cm - 6 mL/sec * 5F Dual Lumen/20 ¢cm - 6 mL/sec

Source page: https://510kreport.com/device/K161866
Methodology: https://510kreport.com/methodology