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FDA 510(k)

RM Electrode (RMH 25-01)

K-Number: K253586 · 2026-04-01

ApplicantRetmap, Inc.
Decision Date2026-04-01
Product CodeHLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RM Electrode (RMH 25-01) is the device name listed in this FDA 510(k) record. The listed applicant is Retmap, Inc.. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K253586. The device is classified under product code HLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RM Electrode (RMH 25-01)?

RM Electrode (RMH 25-01) is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Retmap, Inc.. The 510(k) number is K253586.

When did RM Electrode (RMH 25-01) receive FDA 510(k) clearance?

RM Electrode (RMH 25-01) received FDA 510(k) clearance on 2026-04-01, under 510(k) number K253586.

Who is the listed applicant for RM Electrode (RMH 25-01)?

The FDA 510(k) record lists Retmap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RM Electrode (RMH 25-01)?

The FDA product code for RM Electrode (RMH 25-01) is HLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05509608Evaluating a New Sensor That Measures the Health of the Retina in Normally-sighted SubjectsACTIVE_NOT_RECRUITING

Other records listing Retmap, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232273RM Electrode (RMH 23-01)

Related Devices (Code: HLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232273RM Electrode (RMH 23-01)Retmap, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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