# K971911: Lumax Cystometry Administration Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Medamicus, Inc.
- Decided: Jun 3, 1997 after 36 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 K911865 (1991). 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)
- K911865: Nortec Connecting Tube Set, North American Sterilization & Packaging Co. (1991) Summary page 1.

## Indications for use
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liquid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test.

Source page: https://510kreport.com/device/K971911
Methodology: https://510kreport.com/methodology