510(k) Report

FDA applicant

Memorial Sloan-Kettering Cancer Center

New York, NY1 decision2017–20170 recalls

FDA records 1 decision for Memorial Sloan-Kettering Cancer Center (New York, NY) in 2017: 1 De Novo grant. All are in product code PZM (Next Generation Sequencing Based Tumor…). 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, pathology panel, where it files most

How often FDA has decided Memorial Sloan-Kettering Cancer Center’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Memorial Sloan-Kettering Cancer Center by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PZMNext Generation Sequencing Based Tumor Profiling Test1decision

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • DEN170058MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next…Memorial Sloan-Kettering Cancer Center · 20175cite it

What has FDA decided for it lately?

  • DEN170058MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next…Memorial Sloan-Kettering Cancer Center · 2017

The one decision as Memorial Sloan-Kettering Cancer Center →