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CADENCE

Model 100 · Retina-Ai Health, Inc. · DI B857000

HKI — Camera, Ophthalmic, Ac-Powered · Class II · 21 CFR 886.1120

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-01: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 4/device011202050704
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2021-1201
2022-0201
2023-0501
2025-0703
2026-0404
This device (reports/month)Average device in HKI (reports/device/month)

Regulatory clearances

  • K182199 SESE 2019-01-02 (k number procode)

Predicate lineage

K182199 — cites (transitively): K122572 (d1), K101915 (d2), K101935 (d2), K070231 (d3), K092374 (d3) — cited as predicate by K210197, K230627, K242508

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Retina-Ai Health, Inc.

Nothing in the loaded window.