Cleared Traditional

K191829 - Microlife Non-Contact Infrared Forehead...

K191829 is an FDA 510(k) clearance for Microlife Non-Contact Infrared Forehead..., manufactured by Microlife Intellectual Property GmbH. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K191829 · Microlife Intellectual Property GmbH · General Hospital
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Feb 2020
Decision
219d
Days
Class 2
Risk

K191829 is an FDA 510(k) clearance for the Microlife Non-Contact Infrared Forehead Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH (Widnau, CH). The FDA issued a Cleared decision on February 13, 2020 after a review of 219 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Microlife Intellectual Property GmbH devices

FDA 510(k) Submission Details - K191829

510(k) Number K191829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date February 13, 2020
Days to Decision 219 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Mdi Consultants, Inc.
Susan D. Goldstein-Falk

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 361
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K191829.
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253 · Shenzhen Changkun Technology Co., Ltd. · Jun 2020
Vicks VNT200 No Touch Forehead Thermometer
K193213 · Kaz USA, Inc., A Helen of Troy Company · Apr 2020
Infrared Forehead Thermometer
K190984 · Xiamen Ants Bro Technology Co., Ltd. · Apr 2020
Digital Thermometer
K190990 · Xiamen Ants Bro Technology Co., Ltd. · Dec 2019
Infrared Thermometer, model: PC808
K190717 · Shenzhen Pacom Medical Instruments Co., Ltd. · Dec 2019
Digital Thermometer
K183393 · Joytech Healthcare Co. , Ltd. · Nov 2019