Cleared Traditional

K163603 - Digital Thermometer

K163603 is an FDA 510(k) clearance for Digital Thermometer, manufactured by Guangzhou Jinxinbao Electronic Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K163603 · Guangzhou Jinxinbao Electronic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
167d
Days
Class 2
Risk

K163603 is an FDA 510(k) clearance for the Digital Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Guangzhou Jinxinbao Electronic Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 6, 2017 after a review of 167 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.

FDA 510(k) Submission Details - K163603

510(k) Number K163603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date June 06, 2017
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Elly Xu

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.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 663
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K163603.
Digital Thermometer
K163518 · Joytech Healthcare Co. , Ltd. · Sep 2017
wireless thermometer
K170769 · Ech (Changzhou) Medical Instrument Co., Ltd. · Jul 2017
Microlife Digital Infrared Ear Thermometer
K170219 · Microlife Intellectual Property GmbH · Jul 2017
Braun No Touch + Forehead NTF3000 Thermometer
K163516 · Kaz USA, Inc., A Helen of Troy Company · Apr 2017
VisioFocus Mini, VisioFocus Smart
K160680 · Tecnimed S.R.L. · Apr 2017
Dual Mode Infrared Thermometer
K163256 · Intelliworks, LLC · Apr 2017