Cleared Traditional

K172889 - Infrared Thermometer

K172889 is the FDA 510(k) clearance for Infrared Thermometer by Shenzhen Pacom Medical Instruments Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K172889 · Shenzhen Pacom Medical Instruments Co., Ltd. · General Hospital
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May 2018
Decision
246d
Days
Class 2
Risk

K172889 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 Pacom Medical Instruments Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 25, 2018 after a review of 246 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 Pacom Medical Instruments Co., Ltd. devices

Submission Details

510(k) Number K172889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date May 25, 2018
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K172889.
Infrared Thermometer
K172874 · Shenzhen Jiacom Technology CO ., Ltd. · 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
K172894 · Shenzhen Jiacom Technology CO ., Ltd. · May 2018
Infrared Body Thermometer
K180385 · Hetaida Technology Co., Ltd. · May 2018
AViTA Radar Thermo NT16 Series IR Thermometer
K172427 · Avita Corporation · Apr 2018