← Back to catalogue

Kinsa QuickCare Thermometer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173730

by Kinsa, Inc.

Identifiers

510(k) Number
K173730 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 QuickCare Thermometer is a digital oral, axillary, and rectal thermometer designed for measuring body temperature in patients of all ages, including newborns and infants. Classified under product code FLL, it provides rapid and accurate readings to aid in the assessment of fever or hypothermia in clinical and home settings.

This single-use disposable thermometer is intended for use in general hospital environments and is supplied sterile for immediate clinical application. It requires no cleaning or sterilisation between uses and is compatible with standard medical waste disposal protocols. The device holds FDA 510(k) clearance under the Traditional pathway, with a decision date of January 17, 2018, and is distributed by Kinsa, Inc., based in San Francisco, CA.

Frequently asked questions

Is the Kinsa QuickCare Thermometer reusable or designed for single-use in clinical settings?

The Kinsa QuickCare Thermometer is designed for single-use only in clinical settings. It is supplied sterile and intended for immediate use without cleaning or sterilization between patients, making it ideal for general hospital environments where infection control is critical.

What temperature measurement sites does the Kinsa QuickCare Thermometer support, and is it suitable for newborns and infants?

The Kinsa QuickCare Thermometer measures body temperature orally, axillary (under the arm), and rectally, making it versatile for patients of all ages, including newborns and infants. Its design ensures accuracy across these sites to aid in fever or hypothermia assessment.

How is the Kinsa QuickCare Thermometer disposed of after use, and does it require special handling?

Since it is a single-use, disposable thermometer, the Kinsa QuickCare Thermometer follows standard medical waste disposal protocols—no cleaning or sterilization is needed between uses. This simplifies workflow in clinical settings while maintaining compliance with infection control standards.

What regulatory pathway was used for FDA clearance of the Kinsa QuickCare Thermometer, and when was the decision made?

The Kinsa QuickCare Thermometer received FDA 510(k) clearance under the Traditional pathway, with a decision date of January 17, 2018. This classification confirms its substantial equivalence to a predicate device, ensuring it meets regulatory standards for general hospital use.

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 QuickCare Smart Thermometer, Amazon.com: Kinsa Quickcare Digital Thermometer, Shop Award-Winning Smart Thermometers | Kinsa Health, Kinsa Health Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kinsa, Inc.

Sources (1)

  • FDA 510(k) K173730 24 fields · synced Sep 19, 2026