Cleared Traditional

K171888 - Non-contact infrared body thermometer (FDA 510(k) Clearance)

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

K171888 · Hetaida Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
392d
Days
Class 2
Risk

K171888 is an FDA 510(k) clearance for the Non-contact infrared body thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Hetaida Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 23, 2018 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hetaida Technology Co., Ltd. devices

Submission Details

510(k) Number K171888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date July 23, 2018
Days to Decision 392 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
264d slower than avg
Panel avg: 128d · This submission: 392d
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 796
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K171888.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
K251160 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2026
Ear Thermometer (EAR-E101)
K250470 · Shenzhen AOJ Medical Technology Co., Ltd. · Jun 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · Shenzhen Medke Technology Co., Ltd. · Jun 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2025
Infrared Thermometer
K243082 · Guangzhou Daxin Health Technology Co., Ltd. · Apr 2025
AION TempShield™
K250401 · Aion Biosystems, Inc. · Mar 2025