# K253586: RM Electrode (RMH 25-01)

- Pathway: 510(k) (Traditional)
- Applicant: Retmap, Inc.
- Decided: Apr 1, 2026 after 135 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: 2 generations back to K813399 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232273: RM Electrode (RMH 23-01), Retmap, Inc. (2023) Summary page 5.
- K813399: Erg-Jet Electrode, Nicolet Biomedical Instruments (1982) Summary page 5.

## 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 and multi-focal electroretinogram (ERG) recording procedures. The RM Electrode® is a single use, disposable device.

Source page: https://510kreport.com/device/K253586
Methodology: https://510kreport.com/methodology