510(k) Report

FDA applicant

Aaron Medical Industries

St. Petersburg, FL46 decisions1990–20061 recall

FDA records 46 decisions for Aaron Medical Industries (St. Petersburg, FL) from 1990 to 2006: 46 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HQP (Unit, Cautery, Thermal, Battery-Powered). Its devices cite 28 predicates, 7 of them its own earlier devices. 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Aaron Medical Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aaron Medical Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aaron Medical Industries by year, 2007–2026Sources: 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 & Accessories27decisions
  • HQPUnit, Cautery, Thermal, Battery-Powered4decisions
  • JOSElectrode, Electrosurgical3decisions
  • ETNStimulator, Nerve2decisions
  • HGIElectrocautery, Gynecologic (And Accessories)2decisions
  • FSQLight, Surgical, Instrument1decision

Also: KNS (1), HKP (1), KNF (1), HOG (1), GFE (1), FPA (1).

Whose devices does it build on?

Its devices cite 28 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 37 times; 7 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.

  • K022856Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries · 20035cite it
  • K980366Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240Aaron Medical Industries · 19983cite it
  • K945759High Temperature Cautery 5 LoopAaron Medical Industries · 19952cite it
  • K945492High Temperature CauteryAaron Medical Industries · 19952cite it
  • K945763Low Temperature Cautery Elongated Fine TipAaron Medical Industries · 19952cite it
  • K014201Aaron Reusable Electrosurgical ElectrodeAaron Medical Industries · 20022cite it

What has FDA decided for it lately?

  • K062337Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved); Grasper (Aggressive, Allis…Aaron Medical Industries · 2006
  • K061307Bovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery PackAaron Medical Industries · 2006
  • K060117Bovie Button Remote Hand SwitchAaron Medical Industries · 2006
  • K022856Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries · 2003
  • K021817Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical Generator, 240VAaron Medical Industries · 2002
  • K020579Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03Aaron Medical Industries · 2002
  • K014201Aaron Reusable Electrosurgical ElectrodeAaron Medical Industries · 2002
  • K001955Aaron 1250 High Frequency Electrosurgical Generator, Model A1250Aaron Medical Industries · 2000

All 46 as Aaron Medical Industries →

What has been recalled?

1 recall linked to its devices; the latest:

  • K945765Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414…Jul 12, 2004

Other applicant names beginning “Aaron”

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

Aaron Medical, Inc. 3Aaron Laboratories, Inc. 2