Cleared Traditional

K152680 - TD-1035 Thermometer

K152680 is an FDA 510(k) clearance for TD-1035 Thermometer, manufactured by Taidoc Technology Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K152680 · Taidoc Technology Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
231d
Days
Class 2
Risk

K152680 is an FDA 510(k) clearance for the TD-1035 Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on May 6, 2016 after a review of 231 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 Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K152680

510(k) Number K152680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2015
Decision Date May 06, 2016
Days to Decision 231 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
102d slower than avg
Panel avg: 129d · This submission: 231d
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 378
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K152680.
Microlife Digital Infrared Ear Thermometer
K170219 · Microlife Intellectual Property GmbH · Jul 2017
Non-contact Forehead Thermometer
K161735 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2016
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
Electronic Thermometer
K152739 · Guangdong Biolight Meditech Co., Ltd. · Feb 2016
BASAL DIGITAL THERMOMETER
K141505 · K-Jump Health Co., Ltd. · Aug 2014
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013