510(k) · Cleared
ClearedRM Electrode (RMH 23-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retmap, Inc. · HLZ Electrode, Corneal
Cleared on Dec 7, 2023 as substantially equivalent to K813399 (Nicolet Biomedical Instruments, 1982) after a 129-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.
- Decided
- Dec 7, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- HLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813399 (1982). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K253586RM Electrode (RMH 25-01)Retmap, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813399 | Erg-Jet Electrode | Nicolet Biomedical Instruments | 1982 | — |
| 0 (this device) | K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | 2023 | — |
| +1 | K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HLZ device
- #1 K253586 RM Electrode (RMH 25-01)score 11.4 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K813399 | Erg-Jet ElectrodeSummary page 4…on 21 CFR 886.1220 Type of 510(k) Submission Traditional Legally Marketed Predicate Device ERG Jet Electrode (K813399) 1… | 1982 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HLZ devicesHLZ Electrode, Corneal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HLZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HLZ
Too few HLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HLZ
No recall names HLZ since 2007.
Adverse event reports per year · HLZ
No MAUDE report names HLZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232273: RM Electrode (RMH 23-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026