510(k) Report

FDA applicant

Personal Genome Diagnostics, Inc.

Baltimore, MD3 decisions2020–20260 recalls

FDA records 3 decisions for Personal Genome Diagnostics, Inc. (Baltimore, MD) from 2020 to 2026: 1 510(k) clearance, 1 De Novo grant and 1 original PMA approval. Most are in product codes PZM (Next Generation Sequencing Based Tumor…) and SBY (High Throughput Sequencing Based Tumor…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Personal Genome Diagnostics”.

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 Personal Genome Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Personal Genome Diagnostics, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • PZMNext Generation Sequencing Based Tumor Profiling Test1decision
  • SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic…1decision
  • PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection 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.

  • K192063PGDx elio tissue completePersonal Genome Diagnostics · 20201cites it

What has FDA decided for it lately?

  • P250036PGDx elio tissue complete CDxPersonal Genome Diagnostics, Inc. · 2026
  • DEN230046PGDx elio plasma focus DxPersonal Genome Diagnostics, Inc. · 2024
  • K192063PGDx elio tissue completePersonal Genome Diagnostics · 2020

All 2 as Personal Genome Diagnostics, Inc. →The one decision as Personal Genome Diagnostics →

Other applicant names beginning “Personal”

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

Personal Products Co. 45Personal Sound Technologies, Inc. 2Personal Products Co., Div. of Mcneil Ppc, Inc. 2Personal Products Company, Div. of Mcneil-Ppc, Inc. 2Personal Health & Hygiene, Inc. 1Personal Emergency Response System 1Personal Professional Products, Inc. 1Personal Computers For Medicine, Inc. 1Personal Health Institute International 1