510(k) Report

FDA applicant

Smisson-Cartledge Biomedical, LLC

Alpharetta, GA2 decisions2006–20223 recalls

FDA records 2 decisions for Smisson-Cartledge Biomedical, LLC (Alpharetta, GA) from 2006 to 2022: 2 510(k) clearances. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 6 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices, 3 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Smisson-Cartledge Biomedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2021

2021: 3, 3 Class I
2007high 3 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Smisson-Cartledge Biomedical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LGZWarmer, Thermal, Infusion Fluid2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052055Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 20061cites it

What has FDA decided for it lately?

  • K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC · 2022
  • K052055Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 20063 Class I recalls

All 2 as Smisson-Cartledge Biomedical, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K052055ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor…Feb 18, 2021Class I
  • K052055ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor…Feb 18, 2021Class I
  • K052055ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor…Feb 18, 2021Class I

Other applicant names beginning “Smisson-Cartledge”

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

Smisson-Cartledge 1