Peak.me Peak Flow Meter
by Breathe Me, Ltd. 510(k)
Active
510(k) K180487
Overview
The Peak.me is a Peak Flow Meter, a diagnostic device used to measure peak expiratory flow (PEF) and forced expiratory volume in the first second (FEV₁). It provides quantitative assessment of airflow obstruction, aiding in the diagnosis, monitoring, and management of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).
This single-use, portable device is intended for home use by adults and pediatric patients aged five and older under caregiver supervision. Supplied as a non-sterile, disposable unit, it requires no special storage conditions beyond protection from physical damage. The device carries an FDA 510(k) clearance (K180487) under regulation 868.1860 and is classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180487 | Date26 Oct 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Peak.me
- 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
Questions
What is the Peak.me device used for in clinical practice and who can use it?
The Peak.me is a Peak Flow Meter designed to measure peak expiratory flow (PEF) and forced expiratory volume in the first second (FEV₁), helping assess airflow obstruction for respiratory conditions like asthma and COPD. It is intended for home use by adults and pediatric patients aged five and older, with supervision from a caregiver.
Is the Peak.me device single-use or reusable, and what storage requirements does it have?
The Peak.me is a single-use, disposable device, meaning each unit is intended for one-time use only. It does not require special storage conditions beyond protecting it from physical damage, making it convenient for home use.
What regulatory pathway was followed for the Peak.me, and what class of medical device is it?
The Peak.me received FDA clearance through a traditional 510(k) pathway (K180487) and is classified as a Class II medical device under regulation 868.1860. This classification reflects its role as a diagnostic device for measuring respiratory function.
How does the sterility of the Peak.me device impact its use, and is it safe for repeated patient contact?
The Peak.me is supplied as a non-sterile, disposable unit, meaning it is not sterile and should not be reused or shared between patients. Its single-use design ensures hygiene and safety for individual patients, particularly in home settings.
Are there multiple models or sizes available for the Peak.me, and how would I identify the correct one?
The Peak.me is listed under multiple registration numbers (e.g., 3034603279, 3014335097) but does not specify distinct models or sizes in the provided data. Since it is a single-use device, each unit is standardized for general use by patients aged five and older, so no additional sizing is required beyond age eligibility.