Peak Expiratory Flow Meter KN-9710
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K092335
Overview
The Peak Expiratory Flow Meter KN-9710 is a diagnostic device classified as a Meter, Peak Flow, Spirometry under FDA regulation 868.1860. It measures peak expiratory flow (PEF), a key indicator of airflow obstruction in respiratory assessment, typically used to monitor lung function in clinical and home settings.
This single-use device is intended for use under physician or licensed direction, supplied sterile and packaged for individual patient use. It is classified as a Class II medical device with FDA 510(k) clearance (K092335) and falls under the Anesthesiology specialty category. No third-party review was required for this submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092335 | Date9 Apr 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
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
Other devices from K-jump Health Co., Ltd.
Questions
What is the primary clinical use of the KN-9710 Peak Expiratory Flow Meter and how does it help in patient assessment?
The KN-9710 Peak Expiratory Flow Meter measures peak expiratory flow (PEF), a key metric for assessing airflow obstruction in respiratory conditions. Clinically, it helps monitor lung function—particularly in patients with asthma or chronic obstructive pulmonary disease (COPD)—by quantifying the maximum speed at which air can be exhaled. This aids in evaluating disease progression, response to treatment, and overall respiratory health under physician or licensed direction.
Is the KN-9710 designed for single-use or repeated use, and what does that mean for clinical workflows?
The KN-9710 is explicitly labeled as a single-use device, supplied sterile and packaged for individual patient use. This design ensures hygiene and reduces cross-contamination risk, which is critical in clinical or home settings where multiple patients may use the device. Clinicians should discard it after one use and replace it with a new, sterile unit for subsequent assessments.
What regulatory pathway was followed for FDA clearance of the KN-9710, and what does this mean for its safety and equivalence?
The KN-9710 received FDA 510(k) clearance (K092335) under the Traditional pathway, classified as Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared peak flow meter, ensuring its safety and performance meet regulatory standards. The clearance was filed under the Anesthesiology specialty category, though its clinical use is for respiratory assessment—not anesthesia.
Are there multiple models or sizes available for the KN-9710, and how might this affect patient selection?
The provided data lists multiple registration numbers (e.g., 3034603279, 3014335097, etc.), which typically correspond to different lot or batch identifiers rather than distinct models or sizes. There is no explicit mention of varied sizes or configurations in the specifications. Clinicians should confirm with the manufacturer if specific patient populations (e.g., pediatric vs. adult) require adjustments, as the device’s design appears standardized for general PEF measurement.