Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1
by Microlife Intellectual Property GmbH
510(k) K100953
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100953 | Date17 May 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 is a device intended for the intermittent measurement and monitoring of human body temperature. It is indicated for use by people of all ages in the home setting and supports non-contact measurement of forehead and temporal artery temperature, as well as object measurements.
The device is supplied as a non-sterile, reusable thermometer for use in home environments. It has received FDA 510(k) clearance under K100953 with product code FLL and was determined to be substantially equivalent to a predicate device. No claims regarding sterility, single-use status, MRI safety, or storage conditions are made in the provided data.
Other devices from Microlife Intellectual Property GmbH
Questions
AI-generated answers, 26 Sep 2026
What is the Microlife FR1DZ1 thermometer intended for?
The Microlife FR1DZ1 is intended for the intermittent measurement and monitoring of human body temperature in people of all ages, supporting non-contact forehead and temporal artery temperature readings as well as object measurements in home settings.
Is the Microlife FR1DZ1 thermometer sterile or single-use?
The device is supplied as a non-sterile, reusable thermometer, meaning it is not sterile and is designed for multiple uses in home environments, with no claims made about sterility or single-use status in the provided data.
How was the Microlife FR1DZ1 thermometer cleared for market?
The Microlife FR1DZ1 received FDA 510(k) clearance under submission number K100953, was determined to be substantially equivalent to a predicate device, and cleared via the traditional pathway with product code FLL.