Lifecare Exhalation Valve #06-699

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K873570 ↗

FDA Product Code

CBP

Device Class

Class II

Regulation

21 CFR Part 868.5870

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Lifecare Services, Inc. →

• What clinical setting is the Lifecare Exhalation Valve #06-699 intended for, and how is it used in anesthesia protocols?

  The Lifecare Exhalation Valve #06-699 is designed for use in anesthesia systems within clinical settings like operating rooms or anesthesia workstations. It regulates exhaled gases from a patient, preventing the rebreathing of carbon dioxide while allowing fresh oxygen and anesthetic gases to flow into the breathing circuit. This ensures efficient ventilation during procedures and must be used strictly as part of established anesthesia protocols.

• Is the Lifecare Exhalation Valve #06-699 reusable, or is it meant for single-use only?

  The Lifecare Exhalation Valve #06-699 is explicitly intended for single-use only. It is supplied sterile and must not be reused, as reuse could compromise patient safety and device functionality. Always follow manufacturer guidelines to maintain sterility and proper usage.

• How should the Lifecare Exhalation Valve #06-699 be stored to ensure it remains functional and sterile?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use and sterile upon packaging, it should remain in its original, unopened packaging until use. Avoid exposure to moisture, extreme temperatures, or contamination to prevent degradation.

• What regulatory pathway was followed for FDA clearance of the Lifecare Exhalation Valve #06-699, and what does this mean for its use?

  The Lifecare Exhalation Valve #06-699 received FDA 510(k) clearance under the traditional review pathway, with a decision date of November 30, 1987. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA safety and performance requirements. Clinicians may rely on this clearance as evidence of regulatory compliance for its intended use in anesthesia systems.

• Does the Lifecare Exhalation Valve #06-699 have any specific compatibility or safety considerations, such as MRI use?

  The manufacturer does not provide any MRI safety information for the Lifecare Exhalation Valve #06-699. This means it should not be used in or near MRI environments unless explicitly approved for such use by the manufacturer. Always verify compatibility with your facility’s imaging protocols before use.