Cleared Traditional

K030219 - DIGITAL TEMPERATURE MONITOR

Also marketed or referenced as:
MODEL KY-01

K030219 is an FDA 510(k) clearance for DIGITAL TEMPERATURE MONITOR, manufactured by Kang Ying Medical Appliances, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K030219 · Kang Ying Medical Appliances, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
195d
Days
Class 2
Risk

K030219 is an FDA 510(k) clearance for the DIGITAL TEMPERATURE MONITOR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kang Ying Medical Appliances, Inc. (Tainan County, TW). The FDA issued a Cleared decision on August 5, 2003 after a review of 195 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 Kang Ying Medical Appliances, Inc. devices

FDA 510(k) Submission Details - K030219

510(k) Number K030219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2003
Decision Date August 05, 2003
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
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 479
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K030219.
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364 · Microlife Intellectual Property GmbH · Sep 2003
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658 · Microlife Intellectual Property GmbH · Sep 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958 · Microlife Intellectual Property GmbH · Aug 2003
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K021851 · K-Jump Health Co., Ltd. · Jul 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · Hivox Biotek, Inc. · May 2002