# K961805: Tomey DTL Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation USA
- Decided: May 9, 1997 after 364 days
- Product code: HLZ (Electrode, Corneal)
- Device class: 2
- Regulation: 21 CFR 886.1220
- 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 K820254 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844409: DTL Electrode, Sauquoit Industries, Inc. (1985) Summary page 1.
- K820254: Gold Foil Erg Electrodes, Cadwell Laboratories, Inc. (1982) Summary page 1.
- K823767: Erg-Jet Electrode, Life-Tech Intl., Inc. (1983) Summary page 1.

## Indications for use
The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment.

Source page: https://510kreport.com/device/K961805
Methodology: https://510kreport.com/methodology