# K974775: Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure Gauge

- Pathway: 510(k) (Traditional)
- Applicant: Airtronic Services, Inc.
- Decided: Feb 19, 1998 after 59 days
- Product code: FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device)
- Device class: 2
- Regulation: 21 CFR 876.1620
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The pressure sensor is for use in the long term weekly monitoring of full serial bladder (vesical) pressure in patients that perform regular clean intermittent catheterizations (CIC). Regular once per week long term monitoring of bladder pressure in patients at risk for developing high bladder pressures and urinary incontinence associated with, urinary tract infections (UTI), vesicoureteral reflux and renal insufficiency. The most significant source of urologic morbidity and mortality in patients with spinal conditions where CIC is used is renal failure secondary to upper tract deterioration from high bladder pressures. Cystometry (CMG) is an integral part in the urologic evaluation of patients prior to the use of this device. At no time is this device to be used in place of CMGs for diagnostics. Patients with CMG leak point pressures greater than 40 cm H,0 are at significant risk for upper tract deterioration. The frequency and timing of CMG urodynamic studies in patients with spinal injuries continues to be controversial, but use of this device may insure that full CMGs or other suitable diagnostics are performed on a timely basis by the patients attending physician.

Source page: https://510kreport.com/device/K974775
Methodology: https://510kreport.com/methodology