Cleared Abbreviated

K170262 - Digital Thermometer

K170262 is an FDA 510(k) clearance for Digital Thermometer, manufactured by K-Jump Health Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Abbreviated 510(k) pathway after a 244-day FDA review.

K170262 · K-Jump Health Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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Sep 2017
Decision
244d
Days
Class 2
Risk

K170262 is an FDA 510(k) clearance for the Digital Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on September 28, 2017 after a review of 244 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all K-Jump Health Co., Ltd. devices

FDA 510(k) Submission Details - K170262

510(k) Number K170262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2017
Decision Date September 28, 2017
Days to Decision 244 days
Submission Type Abbreviated
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
115d slower than avg
Panel avg: 129d · This submission: 244d
Pathway characteristics
Standards-based clearance path.

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 K170262.
Infrared thermometer
K171578 · Shenzhen Aeon Technology Co., Ltd. · Nov 2017
Non Contact Infrared Forehead Thermometer
K170662 · Intrinity Global Limited · Nov 2017
ri-former Predictive Thermometer
K171182 · Rudolf Riester GmbH · Oct 2017
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