Cleared Traditional

K233192 - Wireless Smart Thermometer

K233192 is an FDA 510(k) clearance for Wireless Smart Thermometer, manufactured by Famidoc Technology Company Limited. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K233192 · Famidoc Technology Company Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
190d
Days
Class 2
Risk

K233192 is an FDA 510(k) clearance for the Wireless Smart Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Famidoc Technology Company Limited (Dongguan, CN). The FDA issued a Cleared decision on April 5, 2024 after a review of 190 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 Famidoc Technology Company Limited devices

FDA 510(k) Submission Details - K233192

510(k) Number K233192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date April 05, 2024
Days to Decision 190 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
61d slower than avg
Panel avg: 129d · This submission: 190d
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 374
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K233192.
SteadyTemp
K233280 · Steadysense GmbH · Jun 2024
Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
K240648 · Radiant Innovation, Inc. · Jun 2024
Medical electronic thermometer (FC01, FC02)
K240109 · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Apr 2024
Digital Thermometer
K230889 · Wenzhou Yosun Medical Technology Co.,Ltd · Apr 2024
Probe Covers (YF-001, YF-002)
K240023 · Shenzhen YI Fang Blister Packaging Co., Ltd. · Mar 2024
Infrared Thermometer: Model YJ600
K232473 · Zhuhai Yueja Medical Device Technology Co., Ltd. · Feb 2024