510(k) Report

FDA applicant

Hemostatix Medical Technologies, LLC

Bartlett, TN2 decisions2009–20182 recalls

FDA records 2 decisions for Hemostatix Medical Technologies, LLC (Bartlett, TN) from 2009 to 2018: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2018

2009: 12018: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2010

2010: 2
2009high 2 (2010) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Hemostatix Medical Technologies, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

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.

  • K091107Model P8400 Hemostatix Thermal Scalpel SystemHemostatix Medical Technologies, LLC · 20093cite it

What has FDA decided for it lately?

  • K183009Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable BladesHemostatix Medical Technologies, LLC · 2018
  • K091107Model P8400 Hemostatix Thermal Scalpel SystemHemostatix Medical Technologies, LLC · 20092 recalls

All 2 as Hemostatix Medical Technologies, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K033089HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF…Jul 27, 2010
  • K033089MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF…Jul 27, 2010