Peak Flow Meter

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

Full name

Peak Flow Monitor

510(k) Number

K915059 ↗

FDA Product Code

BZH

Device Class

Class II

Regulation

21 CFR Part 868.1860

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Spirometrics Model 2600 Miro Spirometer

  Class II

  FDA 510(k) K901057 Active Cleared 3 Apr 1990

• Spirometrics 2451 & Smi I

  Class II

  FDA 510(k) K844333 Active Cleared 20 Nov 1984

• Spirometrics Model 2141 Spiro-Filter(Tm)

  Class II

  FDA 510(k) K884465 Active Cleared 9 Nov 1988

• Serial Flow

  Class II

  FDA 510(k) K900673 Active Cleared 3 Apr 1990

• Spirometrics Model 2500 Flowmate(Tm)

  Class II

  FDA 510(k) K863953 Active Cleared 15 Jan 1987

• Co/Cmd-1

  Class II

  FDA 510(k) K900322 Active Cleared 30 Apr 1990

See all devices from Spirometrics, Inc. →

• What is the primary clinical use of the Peak Flow Monitor, and how does it help patients with respiratory conditions?

  The Peak Flow Monitor measures peak expiratory flow (PEF), which quantifies the maximum speed of exhaled air from the lungs. It is primarily used to assess and manage respiratory conditions like asthma by providing real-time data on lung function. This helps clinicians monitor treatment effectiveness and patients track their breathing patterns at home or in clinical settings.

• Is the Peak Flow Monitor designed for single-use or repeated use, and what does that mean for maintenance?

  The Peak Flow Monitor is explicitly intended for single-patient use, meaning it is not meant to be shared between patients. However, it is classified as a reusable diagnostic tool—not disposable—so it can be cleaned and reused for the same patient over time. Proper disinfection between uses is required to maintain accuracy and hygiene, following standard medical device protocols for respiratory equipment.

• Are there different sizes or models of the Peak Flow Monitor, and how do I determine which one to order?

  The device data lists multiple registration numbers (e.g., 3034603279, 3014335097), which may correspond to different models or variants of the Peak Flow Monitor. While the exact specifications (e.g., flow range, color-coding, or design) aren’t detailed here, these identifiers suggest Spirometrics may offer variations for clinical or home use. Contact Spirometrics directly for clarification on which model meets your needs, such as pediatric vs. adult-sized mouthpieces or digital vs. analog displays.

• How should the Peak Flow Monitor be stored, and are there any special handling requirements?

  The Peak Flow Monitor follows standard medical device protocols for respiratory diagnostic equipment, which generally include storing it in a clean, dry environment protected from extreme temperatures, moisture, or direct sunlight. Since it is non-sterile and reusable, it should be kept in a dedicated case or storage container when not in use. Always refer to the manufacturer’s instructions for specific cleaning and maintenance procedures to ensure longevity and accuracy.

• What regulatory pathway does the Peak Flow Monitor follow, and how does that affect its use in clinical settings?

  The Peak Flow Monitor is regulated under FDA 510(k) clearance (K915059) as a Class II device under regulation number 868.1860, with a substantially equivalent determination. This means it has undergone FDA review to ensure safety and effectiveness for its intended use—measuring peak expiratory flow—and can legally be marketed and used in U.S. clinical settings. The clearance also confirms it meets performance standards for spirometry meters, though it does not imply any specific clinical indication beyond respiratory monitoring.