510(k) · Cleared
ClearedRM Electrode (RMH 25-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retmap, Inc. · HLZ Electrode, Corneal
Cleared on Apr 1, 2026 as substantially equivalent to K232273 (Retmap, Inc., 2023) and 1 other predicate after a 135-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Apr 1, 2026
- Review
- 135 days
- Class
- Class II
- Product code
- HLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813399 (1982). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K232273 RM Electrode (RMH 23-01)score 9.5 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K232273 | RM Electrode (RMH 23-01)Summary page 5…ication 21 CFR 886.1220 Type of 510(k) Submission Traditional Legally Marketed Predicate Devices RM Electrode (K232273) (primary predicate device) ERG… | 2023 |
| * | K813399 | Erg-Jet ElectrodeSummary page 5…RM Electrode (K232273) (primary predicate device) ERG Jet Electrode (K813399) (secondary predicate device)… | 1982 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 44 years and passes through 2 companies; a new generation was cleared every 41.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All HLZ devicesHLZ Electrode, Corneal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 and multi-focal 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/K253586 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253586: RM Electrode (RMH 25-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253586
Report an extraction error
Are you the manufacturer?
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