Cleared Traditional

K101043 - ECT DIGITAL THERMOMETER

K101043 is an FDA 510(k) clearance for ECT DIGITAL THERMOMETER, manufactured by Changshan Estar Electronics Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K101043 · Changshan Estar Electronics Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
98d
Days
Class 2
Risk

K101043 is an FDA 510(k) clearance for the ECT DIGITAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Changshan Estar Electronics Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on July 21, 2010 after a review of 98 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K101043

510(k) Number K101043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2010
Decision Date July 21, 2010
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 681
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K101043.
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
K101387 · Fudakang Industries Co., Ltd. · Aug 2010
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001
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IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488 · Shenzhen Dongdixin Technology Co., Ltd. · Jul 2010
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001
K101232 · Joinsoon Electronics Mfg Co, Ltd. · Jul 2010
NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
K101736 · Shenzhen Everbest Machinery Industry Co., Ltd. · Jul 2010
RII INFRARED EAR THERMOMETER, MODEL: TH60N
K101253 · Radiant Innovation, Inc. · Jun 2010
K101043 · ECT DIGITAL THERMOMETER
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