# K965115: Round Window Cath

- Pathway: 510(k) (Traditional)
- Applicant: Neuro-Biometrix, Inc.
- Decided: Mar 10, 1997 after 80 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- 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. The FDA summary names its predicate without a number.
- (no number) Microtek Irrigation System (middle ear catheter): named in the summary without a submission number
- (no number) tympanostomy tube: named in the summary without a submission number

## Indications for use
The Round Window u Cath™ (RWuC) is intended to be used by any board certified otolaryngologist or otologist to irrigate the entire middle ear or the round window area of the middle ear. During the course of the irrigation treatment, it is intended that the vent tube through which the RWuC’s dual lumen passes, will aerate the middle ear. The treating physician will choose, based on what he/she feels will be most beneficial for his/her patient, the following: (1) the exact fluids to be delivered through the RWuC; (2) the proper quantities; and (3) the duration and interval of treatment (up to 14 days). It is intended that the physician load the RWuC with the initial fluid to be delivered prior to placement. The RWuC is intended to remain in place for up to 14 days. Neuro-Biometrix, Inc. recommends the physician use only fluids indicated for this use. The physician should refer to the fluid labelling prior to use with the RWuC.

Source page: https://510kreport.com/device/K965115
Methodology: https://510kreport.com/methodology