# Microtek Medical, Inc.

- Location (FDA's records): Columbus, MS
- FDA decisions: 25 (1984–2025): 25 510(k) clearances
- Names in FDA's records: Microtek Medical, Inc. (24); Microtek Medical, LLC (1)
- Product codes: KAE (3), JOW (3), KKX (2), FYA (2), KAL (1), LFB (1), JZB (1), EPP (1), DZI (1), JYJ (1), LHI (1), ETB (1)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 21 (2 its own)
- Recalls linked to its devices: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tyco Healthcare/Kendall: 1 (https://510kreport.com/company/tyco-healthcare-kendall)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Custom Medical Products, Ltd.: 1 (https://510kreport.com/company/custom-medical-products)
- Gcmedica Enterprise Ltd.(Wuxi): 1 (https://510kreport.com/company/gcmedica-enterprise-wuxi)
- Thermogear, Inc.: 1 (https://510kreport.com/company/thermogear)

## Firms that cite its devices most
- Midwest Reprocessing Center, LLC: 4 (https://510kreport.com/company/midwest-reprocessing-center)
- Hygia Health Services, Inc.: 2 (https://510kreport.com/company/hygia-health-services)
- Misonix, Inc.: 2 (https://510kreport.com/company/misonix)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Augustine Biomedical & Design, LLC: 1 (https://510kreport.com/company/augustine-biomedical-design)
- Doctors Orders: 1 (https://510kreport.com/company/doctors-orders)
- Wildcat Medical, Inc.: 1 (https://510kreport.com/company/wildcat-medical)
- Whitney Medical Solutions: 1 (https://510kreport.com/company/whitney-medical-solutions)

## Its most-cited devices
- K011318: Venodyne DVT Advantage Plus (2001), cited by 8
- K050322: Microtek Equipment Drapes (2005), cited by 6
- K001802: Venodyne DVT Advantage Model 610 (2001), cited by 4
- K844061: Microtek Irrigation System (1985), cited by 1
- K022903: Chillbuster (2002), cited by 1
- K102971: Freedomaire Iii Surgical Helmet System Model 10322STK (2011), cited by 1

## Recent decisions
- K251676: Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (Sep 16, 2025)
- K110358: Venodyne V810 (May 5, 2011)
- K102971: Freedomaire Iii Surgical Helmet System Model 10322STK (Feb 23, 2011)
- K062899: Microtek Medical Surgical Gown/Toga (Jan 25, 2007)
- K060200: Microtek Medical Warming Drape (May 31, 2006)
- K050322: Microtek Equipment Drapes (May 17, 2005)
- K022903: Chillbuster (Nov 27, 2002)
- K020956: Vivosonic Dianostic Ultrasound Imaging Coupling Media (May 16, 2002)

Source page: https://510kreport.com/company/microtek-medical