FDA Review Panel · MG

FDA 510(k) Medical Genetics Devices

About Medical Genetics Devices

FDA 510(k) medical genetics devices include instruments and systems used for genetic analysis and molecular diagnostics. The FDA review panel code is MG.

This is a small but rapidly growing category as many genetic tests follow the PMA or De Novo pathway instead of 510(k). Current submissions include:

  • DNA sequencing systems - next-generation sequencing (NGS) platforms
  • PCR-based diagnostic systems - real-time PCR for genetic variant detection
  • Chromosomal analysis instruments - karyotyping and FISH systems

19
Total
11
Cleared
399d
Avg days
2016
Since

FDA 510(k) Cleared Medical Genetics Devices

This page lists all 19 medical devices in the Medical Genetics specialty that have been submitted to the FDA through the 510(k) premarket notification process. Genetic testing systems, molecular diagnostics and genomic analysis tools.

  • 11 devices cleared as substantially equivalent to a predicate device.
  • Average time to FDA decision: 399 days.
  • Records available from 2016 to the present.
  • Filter by product code using the sidebar to narrow results by device type.
1 Medical Genetics devices
1–1 of 1
Not Cleared Sep 19, 2025
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
DEN240067 · Cytocell Limited
SFS · Revumenib Eligibility Detection System · 301d

How to use this database

This page lists 19 medical devices in the Medical Genetics specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 11 were cleared as substantially equivalent to a predicate device. Average FDA review time: 399 days. Records from 2016 to the present.

You can use this list to:

  • Find predicate devices for a new 510(k) submission
  • Verify the clearance status of a specific device
  • Identify FDA product codes related to medical genetics
  • Compare similar cleared devices within this category
  • Research manufacturers active in this specialty

Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.

This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.

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All categories 1 SFS Revumenib Eligibility Detection System 1