Serenity Piezo Sensor, Serenity Thermocouple Sensor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181709 FDA 510(k)
- FDA Product Code
- OLV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a polysomnography accessory consisting of a piezo sensor and a thermocouple sensor. It is designed to collect physiological signals for processing by a host polysomnograph amplifier and PC.
The piezo sensor detects vibrations such as snoring or limb movement via an embedded piezo element and is placed on skin or worn in a heel strap. The device is intended for use by healthcare professionals with adults and children in hospital or laboratory settings.
Frequently asked questions
What is the Serenity Piezo Sensor and Thermocouple Sensor used for?
The device is a polysomnography accessory designed to collect physiological signals such as vibrations from snoring or limb movement via the piezo sensor and temperature data via the thermocouple sensor. These signals are processed by a host polysomnograph amplifier and PC for sleep study analysis in hospital or laboratory settings.
Who is intended to use the Serenity sensor system and in what settings?
The device is intended for use by healthcare professionals with adult and pediatric patients in hospital or laboratory environments. It is not designed for home use or direct patient self-application, but rather as a clinical accessory requiring professional setup and supervision during polysomnography procedures.
How is the Serenity piezo sensor applied during use?
The piezo sensor detects vibrations such as snoring or limb movement through an embedded piezo element and can be placed directly on the skin or worn in a heel strap, depending on the clinical need and patient comfort. This allows flexible positioning to capture movement or respiratory effort signals during sleep studies.
What regulatory pathway was used for the Serenity sensor system?
The device received authorization through the FDA 510(k) premarket notification process, with clearance granted under K181709 on November 16, 2018. It was found substantially equivalent to a predicate device, with a traditional clearance type and product code OLV, indicating its classification as a standard polysomnograph accessory.
What is the device classification and specialty classification for the Serenity sensor system?
The device is classified as a Class II medical device under FDA regulations, with a medical specialty designation in Neurology. This classification reflects its role in neurological diagnostic testing, specifically in the context of sleep disorder evaluation via polysomnography.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Serenity Piezo Sensor, Serenity Thermocouple Sensor (K181709) — FDA 510 ..., Neurotronics Sensors, PDF Neurotronics PZ01 and TH01 510k - accessdata.fda.gov, Serenity Piezo Sensor, Serenity Thermocouple Sensor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181709 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neurotronics, Inc.
Sources (1)
- FDA 510(k) K181709 24 fields · synced Sep 19, 2026