# K973740: Round Window E-Cath

- Pathway: 510(k) (Traditional)
- Applicant: Neuro-Biometrix, Inc.
- Decided: Mar 23, 1998 after 173 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) Round Window p. Cath™: named in the summary without a submission number
- (no number) Ear Electrode: named in the summary without a submission number
- (no number) Transtympanic Needle Electrode: named in the summary without a submission number

## Indications for use
The Round Window E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.

Source page: https://510kreport.com/device/K973740
Methodology: https://510kreport.com/methodology