# K240359: PowerGlide Pro™ Midline Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company (Bard Access Systems, Inc.)
- Decided: Jul 29, 2024 after 174 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: 10 generations back to K932323 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162377: PowerGlide Pro Midline Catheter, C.R. Bard, Inc. (2016) Summary page 5.

## Indications for use
The PowerGlide ProTm Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide ProTM Midline Catheter is suitable for use with power injectors.

Source page: https://510kreport.com/device/K240359
Methodology: https://510kreport.com/methodology