Cleared Traditional

K030658 - STANDARD THERMOMETER

K030658 is an FDA 510(k) clearance for STANDARD THERMOMETER, manufactured by Global Treasure Industries , Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K030658 · Global Treasure Industries , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
22d
Days
Class 2
Risk

K030658 is an FDA 510(k) clearance for the STANDARD THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Global Treasure Industries , Ltd. (Beverly, US). The FDA issued a Cleared decision on March 25, 2003 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K030658

510(k) Number K030658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2003
Decision Date March 25, 2003
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 739
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K030658.
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
THERMO BUDDY, MODELS TB-100, TB-110, TB-120
K023412 · Hubdic Co., Ltd. · Apr 2003
FLEXIBLE TIP THERMOMETER, MODEL 011206
K030673 · Global Treasure Industries , Ltd. · Apr 2003
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
K030324 · Radiant Innovation, Inc. · Feb 2003
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
K030299 · Oriental System Technology, Inc. · Feb 2003
JASUN, MODELS DT-01F AND DT-11F
K030361 · Hangzhou Hua'An Medical & Health Instruments Co., · Feb 2003
K030658 · STANDARD THERMOMETER
Download PDF FDA Summary Global Treasure Indus…