Cleared Traditional

No-contact Forehead Thermometer (K173048) - FDA 510(k) Clearance

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

K173048 · Dongguan Simzo Electronic Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
434d
Days
Class 2
Risk

K173048 is an FDA 510(k) clearance for the No-contact Forehead Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Dongguan Simzo Electronic Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 6, 2018 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Dongguan Simzo Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K173048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date December 06, 2018
Days to Decision 434 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
305d slower than avg
Panel avg: 129d · This submission: 434d
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 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K173048.
Disposable Temperature Probe
K182755 · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 2018
Disposable Temperature Probe
K181967 · Shenzhen Launch Electrical Co., Ltd. · Dec 2018
RII Smart IR Thermometer
K163601 · Radiant Innovation, Inc. · Dec 2018
welloStationX
K180298 · Wello, Inc. · Nov 2018
Non-contact Infrared Thermometer
K180207 · Alicn Medical (Shenzhen), Inc. · Nov 2018
Infrared Thermometer
K182133 · Shenzhen AOJ Medical Technology Co., Ltd. · Nov 2018