510(k) Report

FDA applicant

Genetic

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Genetic (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Genetic since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genetic by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K833021Peri-Guard Pericardial Patch-HerniaGenetic · 19832cite it

What has FDA decided for it lately?

  • K833021Peri-Guard Pericardial Patch-HerniaGenetic · 1983

The one decision as Genetic →

Other applicant names beginning “Genetic”

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

Genetic Systems Corp. 12Genetic Testing Institute 6Genetic Laboratories, Inc. 4Genetic Signatures Limited 1Genetic Laboratories Wound Care, Inc. 1