# K232273: RM Electrode (RMH 23-01)

- Pathway: 510(k) (Traditional)
- Applicant: Retmap, Inc.
- Decided: Dec 7, 2023 after 129 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 K813399 (1982). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813399: Erg-Jet Electrode, Nicolet Biomedical Instruments (1982) Summary page 4.

## Most influential descendants
- K253586: RM Electrode (RMH 25-01) (2026), 0 descendants of its own

## Indications for use
The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions. It is indicated for use in patients aged 12 years and above undergoing diagnostic full-field electroretinogram (ERG) recording procedures. The RM Electrode® is a single use, disposable device.

Source page: https://510kreport.com/device/K232273
Methodology: https://510kreport.com/methodology