Cleared Abbreviated

K180714 - Probe Covers for Thermometers

K180714 is the FDA 510(k) clearance for Probe Covers for Thermometers by K-Jump Health Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Abbreviated 510(k) pathway after a 189-day FDA review.

K180714 · K-Jump Health Co., Ltd. · General Hospital
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Sep 2018
Decision
189d
Days
Class 2
Risk

K180714 is an FDA 510(k) clearance for the Probe Covers for Thermometers. 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 24, 2018 after a review of 189 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

Submission Details

510(k) Number K180714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date September 24, 2018
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K180714.
TD-1035 Thermometer
K172733 · Taidoc Technology Corporation · Oct 2018
Temperature Probe
K173194 · Orantech, Inc. · Oct 2018
Infrared Ear Thermometer
K181081 · Joytech Healthcare Co. , Ltd. · Oct 2018
Fever Scout
K181013 · VivaLNK, Inc. · Aug 2018
Vicks RapidRead Digital Thermometer
K180131 · Kaz USA, Inc., A Helen of Troy Company · Aug 2018
Ageless Health Medical Digital Thermometer
K172508 · Ageless Health Industrial Co., Ltd. · Aug 2018