Cleared Traditional

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (K193338) - FDA 510(k) Clearance

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

K193338 · Shenzhen Med-Link Electronics Tech Co., Ltd. · General Hospital
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Aug 2020
Decision
267d
Days
Class 2
Risk

K193338 is an FDA 510(k) clearance for the Med-link Reusable Temperature Probes, Med-link Disposable 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 August 25, 2020 after a review of 267 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 K193338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date August 25, 2020
Days to Decision 267 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
138d slower than avg
Panel avg: 129d · This submission: 267d
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 K193338.
Infrared Thermometer
K200802 · Shenzhen Urion Technology Co., Ltd. · Oct 2020
Infrared Thermometer Model E127
K201161 · Bioland Technology, Ltd. · Oct 2020
Infrared PT2L Digital No-Touch Thermometer
K200710 · Andon Health Co, Ltd. · Oct 2020
Disposable Temperature Probe
K193625 · Shenzhen Changke Connect Electronics Co., Ltd. · Jul 2020
Infrared Thermometer Model Number RN-50A,RN-50B
K200578 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Jul 2020
iHealth Infrared No-Touch Forehead Thermometer
K200531 · Andon Health Co, Ltd. · Jul 2020