Cleared Traditional

K073366 - TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041

K073366 is an FDA 510(k) clearance for TALKING CLINICAL ELECTRONIC THERMOMETER, 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 70-day FDA review.

K073366 · Shenzhen Dongdixin Technology Co., Ltd. · General Hospital
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Feb 2008
Decision
70d
Days
Class 2
Risk

K073366 is an FDA 510(k) clearance for the TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K073366

510(k) Number K073366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2007
Decision Date February 08, 2008
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
MARK JOB

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.

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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.