Sleep Quality Ventilatory Effort Recorder
by Dynadx Corporation 510(k)
Active
510(k) K070855
Overview
The Sleep Quality Ventilatory Effort Recorder is a ventilatory effort recorder designed to monitor respiratory effort during sleep. It is classified as a Class II medical device and intended for use in assessing ventilatory patterns to aid in the screening of potential sleep apnea or other respiratory disorders in adult patients.
This device is used in clinical or home settings to record ECG data during sleep, with a minimum duration of four hours of predominantly sinus rhythm. Supplied as a reusable device, it is not sterile and requires no specific MRI safety considerations. Authorized under FDA 510(k) clearance (K070855), it adheres to regulatory standards outlined in 21 CFR 868.2375 for ventilatory effort recorders.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070855 | Date20 Mar 2008 | 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- Withdrawn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
- Sleep Quality
- 510(k) Number
- FDA Product Code
- MNR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What clinical scenarios is the Sleep Quality Ventilatory Effort Recorder primarily used for?
The Sleep Quality Ventilatory Effort Recorder is designed to monitor respiratory effort during sleep, specifically to assess ventilatory patterns. It aids in screening for potential sleep apnea or other respiratory disorders in adult patients by recording ECG data for at least four hours of predominantly sinus rhythm. This makes it useful in both clinical and home settings for initial evaluations of suspected sleep-related breathing issues.
Is this device intended for single-use or reusable applications, and does it require sterilization?
The Sleep Quality Ventilatory Effort Recorder is supplied as a reusable device, meaning it is intended for multiple uses. Since it is not sterile, it does not require sterilization between uses, but proper cleaning and maintenance should follow manufacturer guidelines to ensure accurate and reliable performance.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Sleep Quality Ventilatory Effort Recorder was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway with a decision of Substantially Equivalent (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be used for its intended purpose of monitoring respiratory effort during sleep to aid in screening for sleep apnea or respiratory disorders in adult patients.
Does this device have any special considerations for use in environments with MRI machines?
The Sleep Quality Ventilatory Effort Recorder does not require any specific MRI safety considerations, meaning it can be safely used in clinical settings where MRI machines are present without posing risks related to magnetic fields or imaging compatibility.
How many different models or variants of this device are available, and are there specific sizes or configurations?
The provided data lists multiple registration numbers (e.g., 3013689228, 3002806730, etc.), which may correspond to different models or variants of the Sleep Quality Ventilatory Effort Recorder. However, the device description does not specify distinct sizes or configurations beyond its primary function as a ventilatory effort recorder. For precise model details, consulting the manufacturer’s documentation or catalog would be necessary.