Spirotech ST-550 Spirometer

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

Full name

Spirotech St-550

510(k) Number

K840972 ↗

FDA Product Code

BZG

Device Class

Class II

Regulation

21 CFR Part 868.1840

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Spirotech St-5500

  Class II

  FDA 510(k) K823770 Active Cleared 3 Jun 1983

• Spirotech 300

  Class II

  FDA 510(k) K823771 Active Cleared 28 Jan 1983

• What clinical environments is the Spirotech ST-550 Spirometer primarily used in, and why is it suitable for those settings?

  The Spirotech ST-550 Spirometer is designed for use in clinical settings such as anesthesia and pulmonary care environments. Its suitability stems from its role in measuring lung function through gas volume and flow analysis, which is critical for diagnosing and monitoring respiratory conditions. This makes it particularly valuable in areas where precise pulmonary assessments are essential, such as preoperative evaluations, postoperative monitoring, and ongoing respiratory disease management.

• Is the Spirotech ST-550 Spirometer intended for single-use or reusable applications, and what maintenance is required?

  The Spirotech ST-550 Spirometer is supplied as a reusable medical instrument. To ensure accuracy and sterility, it requires proper cleaning and maintenance as outlined in the manufacturer’s instructions. Reusability is important for cost-effectiveness in clinical settings, but adherence to maintenance protocols is critical to preserve performance and comply with regulatory standards.

• How was the regulatory pathway for the Spirotech ST-550 Spirometer determined, and what does this mean for its use?

  The Spirotech ST-550 Spirometer received FDA 510(k) clearance under the Anesthesiology Device category, classified as Class II. This means it was determined to be substantially equivalent to a legally marketed device already on the market, fulfilling the requirements of 21 CFR 868.1840. Clinically, this clearance indicates it meets FDA standards for safety and effectiveness in measuring lung function, ensuring reliable use in diagnostic settings.

• What does the product code BZG signify for the Spirotech ST-550 Spirometer, and how does it relate to its regulatory classification?

  The product code BZG is an administrative identifier used by the FDA for regulatory tracking and classification purposes. It groups the Spirotech ST-550 Spirometer under the broader category of diagnostic spirometers, aligning with its intended use for pulmonary function testing. While it doesn’t describe clinical function, it confirms the device’s classification as a Class II medical device, subject to specific manufacturing and quality control requirements.

• What historical context does the 1984 FDA 510(k) clearance date provide about the Spirotech ST-550 Spirometer’s development?

  The Spirotech ST-550 Spirometer was cleared by the FDA in June 1984 (decision date) following a traditional 510(k) submission received in March 1984. This early clearance reflects its foundational role in pulmonary diagnostics, demonstrating its long-standing presence in clinical settings. The traditional clearance pathway indicates a thorough review by the FDA’s Anesthesiology Device Advisory Committee (AN), ensuring compliance with established safety and performance standards for spirometry devices.