Cleared Traditional

Infrared Thermometer (K172874) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172874 · Shenzhen Jiacom Technology CO ., Ltd. · General Hospital
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Jul 2018
Decision
294d
Days
Class 2
Risk

K172874 is an FDA 510(k) clearance for the Infrared Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Jiacom Technology CO ., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 12, 2018 after a review of 294 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 Shenzhen Jiacom Technology CO ., Ltd. devices

Submission Details

510(k) Number K172874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date July 12, 2018
Days to Decision 294 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
165d slower than avg
Panel avg: 129d · This submission: 294d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K172874.
Non-contact infrared body thermometer
K171888 · Hetaida Technology Co., Ltd. · Jul 2018
Braun BNT400 No Touch + Forehead Thermometer
K181242 · Kaz USA, Inc., A Helen of Troy Company · Jul 2018
Braun BFH175 Infrared Forehead Thermometer
K181015 · Kaz USA, Inc., A Helen of Troy Company · Jul 2018
Infrared Thermometer
K180314 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Jul 2018
Digital Thermometer
K172121 · Fudakang Industrial Co., Ltd. · Jun 2018
Infrared Thermometer
K172889 · Shenzhen Pacom Medical Instruments Co., Ltd. · May 2018