Wright Pocket Peak Flow Meter
by Ferraris Medical, Inc. 510(k)
Active
510(k) K924343
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924343 | Date16 Jun 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZH
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1860
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Wright Pocket Peak Flow Meter is a handheld device classified as a peak flow meter, used to measure the maximum speed of exhaled air from the lungs. It is designed for assessing respiratory function, particularly in patients with conditions such as asthma or chronic obstructive pulmonary disease (COPD). The device provides a quantitative measurement of peak expiratory flow (PEF), aiding in the evaluation of airway obstruction and the effectiveness of respiratory treatments.
This device is supplied as a single-use or reusable instrument, depending on manufacturer guidelines, and is intended for use in clinical, home, or emergency settings. It is not sterile and requires proper cleaning and maintenance if reused. The meter is non-magnetic and safe for use in non-MRI environments. The device is authorized under FDA 510(k) clearance (K924343) and falls under regulation 868.1860, categorized under product code BZH. It is designed for respiratory assessment in the specialty of anesthesiology, though its clinical use extends to broader pulmonary evaluations.
Other devices from Ferraris Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Wright Pocket Peak Flow Meter used for?
The Wright Pocket Peak Flow Meter measures the maximum speed of exhaled air (peak expiratory flow, or PEF) from the lungs. This helps assess airway obstruction and monitor respiratory conditions like asthma or chronic obstructive pulmonary disease (COPD). It provides quantitative data to evaluate treatment effectiveness and track lung function over time.
Is the Wright Pocket Peak Flow Meter sterile?
No, the Wright Pocket Peak Flow Meter is not sterile. If reused, it requires proper cleaning and maintenance to ensure accuracy and hygiene. Always follow manufacturer guidelines for cleaning procedures to maintain device performance and prevent contamination.
Can the Wright Pocket Peak Flow Meter be reused?
Yes, the Wright Pocket Peak Flow Meter can be used either as a single-use or reusable device, depending on manufacturer guidelines. If reused, it must be thoroughly cleaned and maintained to ensure reliable measurements and prevent cross-contamination between patients. Always refer to the manufacturer’s instructions for proper care.
Where can the Wright Pocket Peak Flow Meter be used?
The device is designed for use in clinical settings, home monitoring, and emergency environments. It is particularly useful for assessing respiratory function in patients with asthma or COPD, though its applications extend to broader pulmonary evaluations beyond anesthesiology.
What regulatory approval does the Wright Pocket Peak Flow Meter hold?
The Wright Pocket Peak Flow Meter holds FDA 510(k) clearance under the classification of substantially equivalent devices. It is categorized under product code BZH and falls under regulation 868.1860, with clearance number K924343. This approval indicates it meets regulatory standards for safety and effectiveness as a peak flow meter.