Bodily Fluid Disposal Kit

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

510(k) Number

K961217 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Transidyne General Corp. →

• What is the Bodily Fluid Disposal Kit used for?

  The Bodily Fluid Disposal Kit is designed to safely collect and contain bodily fluids—such as blood, urine, or other secretions—during medical procedures. Its primary purpose is to minimize environmental contamination and lower infection risks in hospital or clinical environments by providing a dedicated, sterile disposal solution.

• Is the kit sterile and single-use?

  Yes, the kit is supplied as a sterile, disposable assembly. Sterility ensures safe use in clinical settings, while the single-use design prevents cross-contamination between patients or procedures, adhering to infection control best practices.

• Where is this kit intended for use?

  The kit is specifically intended for general hospital environments where bodily fluids may be encountered during medical procedures. Its design aligns with clinical settings requiring controlled fluid management to maintain hygiene and safety standards.

• How is the kit regulated?

  The Bodily Fluid Disposal Kit was cleared by the FDA through a 510(k) submission (K961217) as substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory requirements for fluid management devices under product code FXX.

• What materials is the kit made from?

  While the exact material composition isn’t detailed in the provided data, the kit is described as a disposable assembly, likely constructed from medical-grade plastics. These materials are chosen for durability, sterility maintenance, and ease of disposal after single-use.