# DEN130044: Inflow Intraurethral Valve-Pump

- Pathway: De Novo (Direct)
- Applicant: Vesiflo, Inc.
- Decided: Oct 14, 2014 after 354 days
- Product code: PIH (Urethral Insert With Pump For Bladder Drainage)
- Device class: 2
- Regulation: 21 CFR 876.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
indicated for use in female patients 18 years of age or older who have incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers. The device must be replaced every 29 days (or less).

Source page: https://510kreport.com/device/DEN130044
Methodology: https://510kreport.com/methodology