510(k) Report

FDA applicant

Opko Health, Inc.

Miami, FL2 decisions2008–20212 recalls

FDA records 2 decisions for Opko Health, Inc. (Miami, FL) from 2008 to 2021: 1 510(k) clearance and 1 original PMA approval. Most are in product codes OBO (Tomography, Optical Coherence) and QRF (Multi-Analyte Test System With Algorithmic…). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Opko Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 12021: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2023

2022: 12023: 1
2008high 1 (2022) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Opko Health, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBOTomography, Optical Coherence1decision
  • QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K080460Spectral Oct/SloOpko Health, Inc. · 20081cites it

What has FDA decided for it lately?

  • P1900224Kscore TestOpko Health, Inc. · 20212 recalls
  • K080460Spectral Oct/SloOpko Health, Inc. · 2008

All 2 as Opko Health, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P190022The 4Kscore Test, an in vitro serum or plasma test that combines the results of four…Oct 31, 2023Class II
  • P190022The 4Kscore Test is an in vitro serum or plasma test that combines the results of four…Nov 18, 2022Class II

Other applicant names beginning “Opko”

FDA records each applicant name separately; these may or may not be the same firm.

Opko Instrumentation, Inc. 1Opko Diagnostics, LLC 1