Kinsa Smart Thermometer
FDA 510(k)Class II (US FDA 510(k))
by Kinsa, Inc.
Identifiers
- 510(k) Number
- K132514 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Kinsa Smart Thermometer is a digital oral thermometer designed for accurate body temperature measurement. It falls under the category of thermometers, digital and is intended for home use to monitor fever in patients of all ages. The device provides rapid readings and integrates with companion software for enhanced data tracking.
This thermometer is supplied as a single-use or reusable device (as per manufacturer instructions) and is intended for non-invasive use. It is not classified as MRI-safe and must be removed prior to MRI procedures. The device is FDA-cleared under the 510(k) pathway (K132514) and is intended for general hospital and home use. Storage and handling follow standard medical device guidelines to ensure accuracy and hygiene.
Frequently asked questions
How does the Kinsa Smart Thermometer differ in terms of usage between home and hospital settings, and what makes it suitable for both?
The Kinsa Smart Thermometer is designed for both home and general hospital use, as indicated by its FDA clearance under the 510(k) pathway (K132514). It provides rapid, accurate body temperature readings for monitoring fever in patients of all ages, making it versatile for clinical and personal use. The device’s digital functionality and companion software integration enhance data tracking, which is useful in both settings for consistent monitoring and record-keeping.
Is the Kinsa Smart Thermometer intended for single-use only, or can it be reused?
The Kinsa Smart Thermometer can be used either as a single-use device or as a reusable device, depending on the manufacturer’s instructions. This flexibility allows users to choose the option that best fits their needs, whether for hygiene in clinical settings or convenience at home. Always follow the manufacturer’s guidelines for cleaning and reuse to ensure accuracy and safety.
What safety precautions should be taken when using the Kinsa Smart Thermometer in a medical facility, particularly regarding MRI procedures?
The Kinsa Smart Thermometer is not classified as MRI-safe, so it must be removed before any MRI procedure. This precaution is critical to avoid potential interference or damage to the device during imaging. Standard medical device guidelines for storage and handling should also be followed to maintain accuracy and hygiene in clinical environments.
How does the Kinsa Smart Thermometer’s companion software enhance its functionality for users?
The Kinsa Smart Thermometer integrates with companion software to enable enhanced data tracking, allowing users to log and monitor temperature readings over time. This feature is particularly useful for tracking fever trends in patients of all ages, whether in a home or hospital setting, by providing a centralized record of measurements for better health management.
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: Kinsa Health Inc, Kinsa QuickCare Smart Thermometer, Shop Award-Winning Smart Thermometers | Kinsa Health, Kinsa - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132514 | Class II | Active |
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Manufacturer
- Manufacturer
- Kinsa, Inc.
Sources (1)
- FDA 510(k) K132514 24 fields · synced Sep 20, 2026