Cleared Traditional

K051251 - INFRARED EAR THEMOMETER, MODELS DX6603, DX66390

K051251 is an FDA 510(k) clearance for INFRARED EAR THEMOMETER, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K051251

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
Combination Product No
PCCP Authorized No
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.

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 527
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K051251.
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER
K051566 · Proton Healthcare , Ltd. · Jan 2006
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
K051269 · Radiant Innovation, Inc. · Sep 2005
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
K051422 · Medisim, Ltd. · 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