Cleared Traditional

DIGITAL TEMPERATURE MONITOR (K030219) - FDA 510(k) Clearance

Also marketed or referenced as:
MODEL KY-01

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 191
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K030219.
Medline Disposable Electronic Thermometer Probe Cover
K173113 · Medline Industries, Inc. · Jan 2018
Kinsa QuickCare Thermometer
K173730 · Kinsa, Inc. · Jan 2018
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985