PTI-A, PTI-P, PTI-N Disposable Pneumotachs

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K921178 ↗

FDA Product Code

JAX

Device Class

Class II

Regulation

21 CFR Part 868.2550

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Peds Water Filled Catheter/Transducer System

  Class II

  FDA 510(k) K893845 Active Cleared 27 Oct 1989

• Peds Pulmonary Evaluation & Diagnostic System

  Class II

  FDA 510(k) K864087 Active Cleared 7 Nov 1986

• Panda Helium Gas Analyzer

  Class II

  FDA 510(k) K903939 Active Cleared 3 Jan 1991

• Updated Manual for Peds - Pulmonary Eval. & Diag.

  Class II

  FDA 510(k) K881122 Active Cleared 10 Jun 1988

• Pulmonary Forced Flow System (Puffs)

  Class II

  FDA 510(k) K883008 Active Cleared 29 Sep 1988

• What are the PTI-A, PTI-P, and PTI-N disposable pneumotachs used for?

  These pneumotachs are designed specifically for anesthesiology applications to measure airflow during respiratory procedures. They provide precise respiratory flow data, which is critical for patient monitoring and effective ventilation management under anesthesia. The PTI-A model, for example, is tailored for this purpose, ensuring clinicians can track real-time airflow with accuracy.

• Are the PTI-A, PTI-P, and PTI-N pneumotachs sterile and single-use?

  Yes, these pneumotachs are supplied sterile and are intended for single-use only in clinical settings. This design minimizes the risk of cross-contamination and ensures consistent performance for each patient, adhering to best practices for disposable medical devices.

• What regulatory clearance do the PTI-A, PTI-P, and PTI-N pneumotachs hold?

  The PTI-A, PTI-P, and PTI-N disposable pneumotachs are cleared by the FDA under the 510(k) pathway with clearance number K921178. They are classified as Class II devices under FDA regulation 868.2550 and are reviewed by the Anesthesiology Advisory Committee. This clearance confirms their substantial equivalence to a predicate device and compliance with safety and performance standards for respiratory measurement tools.

• How should these pneumotachs be stored?

  While specific storage conditions are not detailed in the regulatory submission, disposable medical devices like these pneumotachs are generally stored in a clean, dry environment protected from direct sunlight and extreme temperatures. Proper packaging should be maintained until use to preserve sterility and functionality.

• Can these pneumotachs be reused?

  No, these pneumotachs are explicitly designed for single-use only. Reusing them could compromise patient safety by introducing contamination or altering measurement accuracy. The disposable nature ensures each device is used once per patient, adhering to clinical hygiene standards.