Cleared Traditional

K160358 - DT-100

K160358 is an FDA 510(k) clearance for DT-100, manufactured by Mediana Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K160358 · Mediana Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K160358

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

International Regulatory Consultants
Charlie Mack

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K160358.
VisioFocus Mini, VisioFocus Smart
K160680 · Tecnimed S.R.L. · Apr 2017
Dual Mode Infrared Thermometer
K163256 · Intelliworks, LLC · Apr 2017
Infrared Non-contact Thermometer, Model ACT8100
K162509 · Easywell Biomedicals, Inc. · Mar 2017
Fever Scout™ Continuous Monitoring thermometer
K162137 · VivaLNK, Inc. · Jan 2017
RII Multi-function Infrared Thermometer, Model TH52Z
K162083 · Radiant Innovation, Inc. · Jan 2017
Cloud Smart Thermometer
K160306 · Guangzhou Bosma Technology Co, Ltd. · Dec 2016