510(k) Report

FDA applicant

Microtek Medical, Inc.

Columbus, MS25 decisions1984–202518 recalls

FDA records 25 decisions for Microtek Medical, Inc. (Columbus, MS) from 1984 to 2025: 25 510(k) clearances. Most are in product codes KAE (Forceps, Ent) and JOW (Sleeve, Limb, Compressible). Its devices cite 7 predicates, 2 of them its own earlier devices. 18 recalls are linked to its devices.

FDA’s records also spell it “Microtek Medical, LLC”.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2025

2007: 12011: 22025: 1
2007high 2 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2010: 12013: 12015: 142018: 1
2007high 14 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Microtek Medical, Inc.’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?

  • KAEForceps, Ent3decisions
  • JOWSleeve, Limb, Compressible3decisions
  • KKXDrape, Surgical, Antimicrobial2decisions
  • FYAGown, Surgical2decisions
  • KALRetractor, Ent1decision
  • LFBButton, Nasal Septal1decision

Also: JZB (1), EPP (1), DZI (1), JYJ (1), LHI (1), ETB (1).

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 2 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.

  • K011318Venodyne DVT Advantage PlusMicrotek Medical, Inc. · 20018cite it
  • K050322Microtek Equipment DrapesMicrotek Medical, Inc. · 20056cite it
  • K001802Venodyne DVT Advantage Model 610Microtek Medical, Inc. · 20014cite it
  • K844061Microtek Irrigation SystemMicrotek Medical, Inc. · 19851cites it
  • K022903ChillbusterMicrotek Medical, Inc. · 20021cites it
  • K102971Freedomaire Iii Surgical Helmet System Model 10322STKMicrotek Medical, Inc. · 20111cites it

What has FDA decided for it lately?

  • K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S)…Microtek Medical, LLC · 2025
  • K110358Venodyne V810Microtek Medical, Inc. · 2011
  • K102971Freedomaire Iii Surgical Helmet System Model 10322STKMicrotek Medical, Inc. · 2011
  • K062899Microtek Medical Surgical Gown/TogaMicrotek Medical, Inc. · 2007
  • K060200Microtek Medical Warming DrapeMicrotek Medical, Inc. · 20061 recall
  • K050322Microtek Equipment DrapesMicrotek Medical, Inc. · 200517 recalls
  • K022903ChillbusterMicrotek Medical, Inc. · 2002
  • K020956Vivosonic Dianostic Ultrasound Imaging Coupling MediaMicrotek Medical, Inc. · 2002

All 24 as Microtek Medical, Inc. →The one decision as Microtek Medical, LLC →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K060200Maximal Barrier Drape; Product Codes: ASK-00002-1AApr 11, 2018Class II
  • K050322da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical…Mar 16, 2015Class II
  • K050322da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek…Mar 16, 2015Class II
  • K050322da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment…Mar 16, 2015Class II
  • K050322da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Mar 16, 2015Class II
  • K050322da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical…Mar 16, 2015Class II

Other applicant names beginning “Microtek”

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

Microtek Medical, Inc. an Ecolab Company 1Microtek-Heritage, Inc. 1Microtek International, Inc. 1