510(k) Report

FDA applicant

Thermedx, LLC

Solon, OH5 decisions2010–20213 recalls

FDA records 5 decisions for Thermedx, LLC (Solon, OH) from 2010 to 2021: 5 510(k) clearances. Most are in product codes HIG (Insufflator, Hysteroscopic) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 11 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2021

2010: 12011: 12014: 12017: 12021: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2026

2014: 22026 (partial year): 1
2010high 2 (2014) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Thermedx, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HIGInsufflator, Hysteroscopic4decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K172048FluidSmartThermedx, LLC · 20172cite it
  • K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 20101cites it
  • K133799Thermedx Fluid Managment SystemThermedx, LLC · 20141cites it

What has FDA decided for it lately?

  • K210628X-FLO Fluid Management SystemThermedx, LLC · 2021
  • K172048FluidSmartThermedx, LLC · 20171 recall
  • K133799Thermedx Fluid Managment SystemThermedx, LLC · 20142 recalls
  • K102275Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240Thermedx, LLC · 2011
  • K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 20102 recalls

All 5 as Thermedx, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K172048Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The…Apr 9, 2026Class II
  • K091939Fluid Management System P4000; for irrigation and fluid warming in laparoscopic…Sep 1, 2014Class II
  • K091939The Thermedx Fluid Management System is designed to provide irrigation fluids to…Feb 10, 2014Class II