Cleared Traditional

DT-100 (K160358) - FDA 510(k) Clearance

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

K160358 · Mediana Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2017
Decision
381d
Days
Class 2
Risk

K160358 is an FDA 510(k) clearance for the DT-100. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mediana Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on February 24, 2017 after a review of 381 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 Mediana Co., Ltd. devices

Submission Details

510(k) Number K160358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2016
Decision Date February 24, 2017
Days to Decision 381 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
252d slower than avg
Panel avg: 129d · This submission: 381d
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 797
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K160358.
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K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2025
Infrared Thermometer
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