510(k) Report

FDA applicant

Rg Ent., Inc.

Southfield, MI3 decisions1996–20060 recalls

FDA records 3 decisions for Rg Ent., Inc. (Southfield, MI) from 1996 to 2006: 3 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and FLK (Thermometer, Clinical Mercury). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Rg Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rg Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rg Ent., 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?

  • DWJSystem, Thermal Regulating2decisions
  • FLKThermometer, Clinical Mercury1decision

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.

  • K051097Geratherm Sos-Rescue BlanketRg Ent., Inc. · 20061cites it

What has FDA decided for it lately?

  • K051278Geratherm Sos-Vacutherm (Thermamed Smartcare)Rg Ent., Inc. · 2006
  • K051097Geratherm Sos-Rescue BlanketRg Ent., Inc. · 2006
  • K960224Geratherm Mercuiry Free Clinical ThermometerRg Ent., Inc. · 1996

All 3 as Rg Ent., Inc. →