510(k) Report

FDA applicant

Jac-Cell Medic Corporation

Maineville, OH2 decisions2002–20170 recalls

FDA records 2 decisions for Jac-Cell Medic Corporation (Maineville, OH) from 2002 to 2017: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Jac-Cell Medic”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Jac-Cell Medic Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Jac-Cell Medic Corporation’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K020334Insulation and Continuity Tester Plus Accessories; Models ATI014 & ATI014 FCJac-Cell Medic Corporation · 20023cite it

What has FDA decided for it lately?

  • K170105Jac-Cell Medic testersJac-Cell Medic · 2017
  • K020334Insulation and Continuity Tester Plus Accessories; Models ATI014 & ATI014 FCJac-Cell Medic Corporation · 2002

The one decision as Jac-Cell Medic Corporation →The one decision as Jac-Cell Medic →