# K983325: IN-Probe II Urodynamic System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Nov 24, 1998 after 63 days
- Product code: FEN (Device, Cystometric, Hydraulic)
- 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
Longest line of descent: 1 generation back to K940812 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940812: Insight Electronic Alignment Indicator, Andronic Devices, Ltd. (1994) Summary page 1.
- (no number) In-Probe Urodynamics System: named in the summary without a submission number
- (no number) pre-amendments Q-tip test: named in the summary without a submission number

## Indications for use
The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.

Source page: https://510kreport.com/device/K983325
Methodology: https://510kreport.com/methodology