Disposable Pulmonary Function Filter

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

510(k) Number

K951410 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• DX1

  Class II

  FDA 510(k) K951227 Active Cleared 11 Aug 1995

• The Portable Family - Medi-Facts DX1 Portable Lite and DX1 Portable Plus

  Class II

  FDA 510(k) K964939 Active Cleared 6 Mar 1997

• DX1-Portable

  Class II

  FDA 510(k) K951157 Active Cleared 11 Aug 1995

• What clinical settings is the Disposable Pulmonary Function Filter intended for use in, and why is this important?

  The Disposable Pulmonary Function Filter is designed for use in clinical settings such as operating rooms and pulmonary function laboratories. This is important because it ensures sterile airflow to patients during procedures like pulmonary function testing or anesthesia delivery, preventing contamination of the airway and maintaining patient safety in high-risk environments.

• How is the Disposable Pulmonary Function Filter supplied, and what does this mean for its usability?

  The device is supplied sterile and is intended for single-use only. This means it is ready to use immediately upon opening, eliminating the need for sterilization between patients and reducing the risk of cross-contamination. Its non-reusable nature also simplifies inventory management and ensures consistent performance.

• What regulatory pathway was followed for the FDA clearance of this device, and what does this classification mean for its safety standards?

  The Disposable Pulmonary Function Filter received FDA clearance through a 510(k) submission, classified as a Class II medical device under regulation number 868.5260. This classification indicates it poses moderate risk and requires compliance with specific controls to ensure its safety and effectiveness, including design controls and labeling requirements, without requiring the rigorous premarket approval process of Class III devices.

• Are there different sizes or models available for the Disposable Pulmonary Function Filter, and if so, how might this affect its application?

  The provided data does not specify distinct sizes or models for the Disposable Pulmonary Function Filter, but the OpenFDA registration numbers suggest multiple lot or batch identifiers may exist for inventory or traceability purposes. Clinicians should confirm compatibility with their specific breathing circuit systems, as the filter’s primary function is to integrate seamlessly without compromising airflow or sterility.

• What should clinicians consider regarding storage and handling of the Disposable Pulmonary Function Filter to maintain its integrity?

  Since the filter is sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its sterility and functionality. Clinicians should check expiration dates and ensure the packaging remains intact before use, as any compromise could risk contamination or performance issues during pulmonary testing or anesthesia.