510(k) Report

FDA applicant

Fifth Eye, Inc.

Ann Arbor, MI3 decisions2021–20220 recalls

FDA records 3 decisions for Fifth Eye, Inc. (Ann Arbor, MI) from 2021 to 2022: 2 510(k) clearances and 1 De Novo grant. All are in product code QNV (Adjunctive Hemodynamic Indicator With Decision…). Its devices cite 3 predicates, 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2022

2021: 22022: 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Fifth Eye, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • QNVAdjunctive Hemodynamic Indicator With Decision Point3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. · 20212cite it
  • K212219AHI SystemFifth Eye, Inc. · 20211cites it

What has FDA decided for it lately?

  • K221203AHI SystemFifth Eye, Inc. · 2022
  • K212219AHI SystemFifth Eye, Inc. · 2021
  • DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. · 2021

All 3 as Fifth Eye, Inc. →