Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs

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

510(k) Number

K060866 ↗

FDA Product Code

LHI

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Infusion Adapter C100

  Class II

  FDA 510(k) K110023 Active Cleared 12 Apr 2011

• Phaseal

  Class II

  FDA 510(k) K023747 Active Cleared 15 Nov 2002

• Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,

  Class II

  FDA 510(k) K092782 Active Cleared 7 Dec 2009

• Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro

  Class II

  FDA 510(k) K980381 Active Cleared 3 Mar 1998

• Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter

  Class II

  FDA 510(k) K001368 Active Cleared 12 May 2000

• Phaseal Protector P14, P21, P28 and P50

  Class II

  FDA 510(k) K090634 Active Cleared 23 Mar 2009

• What is the Phaseal closed system primarily designed to protect against during the handling and administration of parenteral drugs?

  The Phaseal closed system is specifically designed to minimize environmental exposure to hazardous medications, particularly cytotoxic drugs. Its closed components prevent leakage during preparation and administration, reducing the risk of contamination or accidental exposure for healthcare workers and patients.

• Is the Phaseal system intended for use outside of hospital settings, or is it strictly for in-hospital use?

  The Phaseal closed system is explicitly intended for use in hospital settings only, as stated in its description. The design and safety features align with controlled clinical environments where hazardous drug handling requires stringent containment measures.

• Are the components of the Phaseal system reusable, or are they meant to be used only once?

  The Phaseal system is supplied as a sterile, single-use device, meaning each component is intended for one-time use within the designated closed system. While the system itself is reusable as part of the closed setup, individual parts are not meant to be reused outside of their intended configuration.

• How does the Phaseal system ensure safety for healthcare workers when handling cytotoxic drugs?

  The Phaseal system achieves safety by creating a closed environment that prevents leakage during preparation and administration. This containment reduces the risk of accidental exposure to cytotoxic drugs, which are known to be hazardous to healthcare workers if spilled or aerosolized during handling.

• What regulatory pathway did the Phaseal system follow to gain clearance, and what does that mean for its intended use?

  The Phaseal system received FDA 510(k) clearance under Special classification (K060866), meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms its compliance with U.S. regulatory standards for infusion pumps and drug delivery systems, ensuring it meets safety and performance requirements for hospital use.