Miltex Thompson Cassettes

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Miltex Thompson Cassettes; Miltex Surgical Cassettes

510(k) Number

K101653 ↗

FDA Product Code

KCT

Models / Variants

Miltex Thompson Cassettes

Miltex Surgical Cassettes

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Miltex Rigid Sterilization Container System, (47 Components)

  Class II

  FDA 510(k) K061033 Active Cleared 12 Dec 2006

• Miltex Membrane Tack Kit

  Class II

  FDA 510(k) K092855 Active Cleared 29 Dec 2009

• Dental Instruments - Cutting Instrument

  Class I

  FDA 510(k) K823326 Active Cleared 24 Nov 1982

• Dental Instruments - Files

  Class I

  FDA 510(k) K823316 Active Cleared 24 Nov 1982

• Dental Instruments - Probes

  Class I

  FDA 510(k) K823324 Active Cleared 24 Nov 1982

• Dental Instruments - Excavators

  Class I

  FDA 510(k) K823318 Active Cleared 24 Nov 1982

See all devices from Miltex, Inc. →

• Are these cassettes meant for single-use or can they be reused in multiple procedures?

  The Miltex Thompson Cassettes are explicitly designed as reusable surgical instrument trays. Since they are categorized under surgical trays and lack any single-use labeling or sterilization instructions in the provided data, they are intended for repeated use after proper cleaning and sterilization between procedures.

• What are the most common sizes available for these cassettes, and how might that affect my workflow?

  The cassettes come in two primary dimensions: 8 x 3 13/16 x 1 1/8 inches (204 x 81 x 30 mm) and 8 x 10 7/8 x 1 3/16 inches (204 x 276.5 x 30 mm). The smaller size is ideal for compact setups or procedures requiring fewer instruments, while the larger size accommodates more tools, making it suitable for complex surgeries or high-volume workflows where space efficiency is critical.

• How does the lid design of these cassettes improve usability in an operating room?

  The Miltex Thompson Cassettes feature a double-hinged, tuck-away lid, which allows for secure closure while keeping instruments organized. This design prevents accidental spills or dislodging of tools during transport, and the tuck-away mechanism ensures the lid stays neatly contained when closed—reducing clutter on the surgical field and streamlining workflow efficiency.

• Are these cassettes compatible with standard hospital sterilization processes, or do they require special handling?

  Since the cassettes are reusable and lack any proprietary sterilization instructions in the provided data, they should be compatible with standard hospital sterilization methods (e.g., autoclave, ethylene oxide, or low-temperature plasma). However, it’s always best to verify compatibility with your facility’s specific sterilization protocols to ensure longevity and safety.

• How do I determine which advisory committee or product code category this cassette falls under for regulatory or procurement purposes?

  These cassettes are classified under the General Hospital advisory committee (HO) and carry the product code KCT in the FDA’s database. This categorization is based on their intended use as reusable surgical trays, which helps streamline procurement, inventory tracking, and regulatory compliance in hospital settings.