Cleared Traditional

K172889 - Infrared Thermometer

K172889 is an FDA 510(k) clearance for Infrared Thermometer, manufactured by Shenzhen Pacom Medical Instruments Co., Ltd.. The device is a Class 2 General Hospital device with 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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K172889

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.

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 794
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
K172889 · Infrared Thermometer
Download PDF FDA Summary Shenzhen Pacom Medica…