Sensaire Diagnostic Spirometer

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

510(k) Number

K001278 ↗

FDA Product Code

BZG

Device Class

Class II

Regulation

21 CFR Part 868.1840

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modification to: Bpcard, Model Z-7000-0700

  Class II

  FDA 510(k) K073630 Active Cleared 11 Jan 2008

• Spiroxcard Diagnostic Spirometer and Pulse Oximeter

  Class II

  FDA 510(k) K001995 Active Cleared 8 Sep 2000

• CARDIOVIEW32 Review Module

  Not classified

  FDA 510(k) K083749 Active Cleared 10 Mar 2009

• Ekgcard System

  Class II

  FDA 510(k) K030535 Active Cleared 11 Jun 2003

• SpiroCard

  Class II

  FDA 510(k) K973138 Active Cleared 28 Oct 1998

• BPCard

  Class II

  FDA 510(k) K031964 Active Cleared 5 Sep 2003

• What types of respiratory conditions can the Sensaire Diagnostic Spirometer help diagnose or monitor?

  The Sensaire Diagnostic Spirometer is designed to measure lung function parameters like forced expiratory volume (FEV) and forced vital capacity (FVC), which are critical for assessing respiratory health. It aids in diagnosing and monitoring conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders by providing objective data for clinical evaluation.

• Is the Sensaire Diagnostic Spirometer intended for single-use or reusable settings, and how should it be handled?

  The device is intended for use in both single-use and reusable clinical settings, depending on facility protocols. While it is not explicitly labeled as sterile, its design and regulatory classification (Class II) imply it must be handled according to standard infection control practices to ensure patient safety, particularly if reused.

• What environments is the Sensaire Diagnostic Spirometer suitable for, and does it require any additional equipment?

  The Sensaire Diagnostic Spirometer is a portable, self-contained unit designed for use in environments like physician offices, clinics, and hospitals. It does not require additional calibration equipment, making it convenient for point-of-care respiratory assessments.

• How is the regulatory status of the Sensaire Diagnostic Spirometer determined, and what does that mean for users?

  The device holds FDA 510(k) clearance (K001278) and is classified as Class II, meaning it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance ensures it meets regulatory standards outlined in 21 CFR 868.1840, providing users with confidence in its safety and performance for diagnostic respiratory assessments.

• Are there different models or sizes available for the Sensaire Diagnostic Spirometer, and how would I know which one to choose?

  The provided data lists multiple registration numbers (e.g., 3008717264, 3030447506) associated with the device, which may indicate variations or different lots, but no explicit details on distinct models or sizes are given. Typically, the choice would depend on facility needs, such as portability or specific clinical workflows, but further clarification from the manufacturer (Qrs Diagnostic, LLC) would be necessary to determine compatibility or differences.