510(k) Report

FDA applicant

Retmap, Inc.

Chicago, IL2 decisions2023–20260 recalls

FDA records 2 decisions for Retmap, Inc. (Chicago, IL) from 2023 to 2026: 2 510(k) clearances. All are in product code HLZ (Electrode, Corneal). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Retmap, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 12026 (partial year): 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Retmap, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Retmap, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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