Cleared Traditional

K161735 - Non-contact Forehead Thermometer

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

K161735 · Shenzhen Dongdixin Technology Co., Ltd. · General Hospital
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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

Submission Details

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
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.

Device Classification

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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K161735.
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Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
TD-1035 Thermometer
K152680 · Taidoc Technology Corporation · May 2016
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013