Cleared Abbreviated

K070491 - DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K070491 · K-Jump Health Co., Ltd. · General Hospital
Jun 2007
Decision
121d
Days
Class 2
Risk

K070491 is an FDA 510(k) clearance for the DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on June 21, 2007 after a review of 121 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K070491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date June 21, 2007
Days to Decision 121 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 169d · This submission: 121d
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 14
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K070491.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
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YUWELL® Infrared Ear Thermometer (YHT100)
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Infrared Thermometer
K243082 · Guangzhou Daxin Health Technology Co., Ltd. · Apr 2025
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
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