# K150407: BioFlo Midline Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: May 15, 2015 after 86 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932323 (1993). 23 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133856: Powerglide Midline Catheter, C.R. Bard, Inc. (2014) Summary page 4.

## Most influential descendants
- K203069: HydroMID (2021), 3 descendants of its own
- K220772: HydroMID 4F Single Lumen Midline Catheter (2022), 2 descendants of its own
- K243458: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (2025), 0 descendants of its own
- K244059: HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (2025), 0 descendants of its own
- K161866: BioFlo Midline Catheter (2016), 0 descendants of its own

## Indications for use
The BioFlo Midline is indicated for short term access (<30 days) 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. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600 mOsm/L. Maximum Power Injection Flow Rate: -3F Single Lumen, 20 cm: 2 mI/sec -4F Single Lumen, 20 cm: 6 mI/sec -5F Single Lumen, 20 cm: 6 mL/sec -5F Dual Lumen, 20 cm: 6 mL/scc

Source page: https://510kreport.com/device/K150407
Methodology: https://510kreport.com/methodology