Cleared Traditional

K161735 - Non-contact Forehead Thermometer

K161735 is an FDA 510(k) clearance for Non-contact Forehead Thermometer, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K161735 · Shenzhen Dongdixin Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
147d
Days
Class 2
Risk

K161735 is an FDA 510(k) clearance for the Non-contact Forehead Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 17, 2016 after a review of 147 days - within the typical 510(k) review window.

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 Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K161735

510(k) Number K161735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2016
Decision Date November 17, 2016
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 Peers - FLL Continuous Measurement Thermometer

All 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K161735.
RII Multi-function Infrared Thermometer, Model TH52Z
K162083 · Radiant Innovation, Inc. · Jan 2017
Cloud Smart Thermometer
K160306 · Guangzhou Bosma Technology Co, Ltd. · Dec 2016
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
K161728 · Microfile Intellectual Property GmbH · Dec 2016
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
K160816 · Nexmed Technology Co., Ltd. · Sep 2016
Digital Thermometer
K161211 · Biocare Asia Corporation , Ltd. · Aug 2016
Infrared Forehead Thermometer, FT-100A
K160802 · Hangzhou Universal Electronic Co., Ltd. · Aug 2016