Cleared Traditional

K120711 - NON-CONTACT THERMOMETER

K120711 is an FDA 510(k) clearance for NON-CONTACT THERMOMETER, manufactured by K-Jump Health Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K120711 · K-Jump Health Co., Ltd. · General Hospital
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Nov 2012
Decision
256d
Days
Class 2
Risk

K120711 is an FDA 510(k) clearance for the NON-CONTACT 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 November 19, 2012 after a review of 256 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.

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

FDA 510(k) Submission Details - K120711

510(k) Number K120711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date November 19, 2012
Days to Decision 256 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
127d slower than avg
Panel avg: 129d · This submission: 256d
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 K120711.
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
K121999 · Draeger Medical GmbH · Feb 2013
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K123361 · Fiab Spa · Feb 2013
DIGITAL THERMOMTER
K122520 · Taidoc Technology Corporation · Feb 2013
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
K122912 · Hangzhou Hua'An Medical & Health Instruments Co., · Nov 2012
WIRELESS THERMOMETER
K121696 · Raling Medical Company · Oct 2012
INFRARED THERMOMETER
K113761 · Famidoc Technology Co., Ltd. · Sep 2012