Cleared Traditional

Med-link Temperature Probes (K182667) - FDA 510(k) Clearance

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

K182667 · Shenzhen Med-Link Electronics Tech Co., Ltd. · General Hospital
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Jun 2019
Decision
266d
Days
Class 2
Risk

K182667 is an FDA 510(k) clearance for the Med-link Temperature Probes. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 18, 2019 after a review of 266 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 Med-Link Electronics Tech Co., Ltd. devices

Submission Details

510(k) Number K182667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2018
Decision Date June 18, 2019
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 214
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K182667.
Advocate Non-Contact Infrared Thermometer
K191004 · Broadmaster Biotech, Corp. · Sep 2019
Infrared Ear/Forehead Thermometer
K190873 · Joytech Healthcare Co. , Ltd. · Jul 2019
Microlife Digital Infrared Ear Thermometer
K183663 · Microlife Intellectual Property GmbH · Jul 2019
Medline Digital Rectal Thermometer Sheath
K183431 · Medline Industries, Inc. · Jun 2019
Wireless Intelligent Thermometer
K182437 · Shenzhen Jumper Medical Equipment Co., Ltd. · May 2019
Infrared thermometer
K182597 · Shenzhen Pango Electronic Co., Ltd. · Apr 2019