Cleared Traditional

K051251 - INFRARED EAR THEMOMETER

K051251 is the FDA 510(k) clearance for INFRARED EAR THEMOMETER by Shenzhen Dongdixin Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K051251 · Shenzhen Dongdixin Technology Co., Ltd. · General Hospital
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Sep 2005
Decision
114d
Days
Class 2
Risk

K051251 is an FDA 510(k) clearance for the INFRARED EAR THEMOMETER, MODELS DX6603, DX66390. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 7, 2005 after a review of 114 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.

View all Shenzhen Dongdixin Technology Co., Ltd. devices

Submission Details

510(k) Number K051251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date September 07, 2005
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K051251.
CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
K061800 · Taidoc Technology Corporation · Jul 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173 · ACON Laboratories, Inc. · Mar 2006
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · Omron Healthcare, Inc. · Jun 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · Microlife Intellectual Property GmbH · May 2005