510(k) Report

FDA applicant

Promega Corporation

Madison3 decisions2021–20260 recalls

FDA records 3 decisions for Promega Corporation (Madison) from 2021 to 2026: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes SFL (Nucleic Acid Based Assay, Microsatellite…) and PZJ (Lynch Syndrome Test System). Its devices cite 1 predicate, 0 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

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

FDA decisions per year

1in 2025

2021: 12025: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

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Which product codes does it file in?

  • SFLNucleic Acid Based Assay, Microsatellite Instability2decisions
  • PZJLynch Syndrome Test System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K200129OncoMate MSI Dx Analysis SystemPromega Corporation · 20211cites it

What has FDA decided for it lately?

  • P250046OncoMate® MSI Dx Analysis SystemPromega Corporation · 2026
  • P240026OncoMate® MSI Dx Analysis SystemPromega Corporation · 2025
  • K200129OncoMate MSI Dx Analysis SystemPromega Corporation · 2021

All 3 as Promega Corporation →