Cleared Traditional

K023412 - THERMO BUDDY, MODELS TB-100, TB-110, TB-120

K023412 is an FDA 510(k) clearance for THERMO BUDDY, manufactured by Hubdic Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K023412 · Hubdic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
180d
Days
Class 2
Risk

K023412 is an FDA 510(k) clearance for the THERMO BUDDY, MODELS TB-100, TB-110, TB-120. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Hubdic Co., Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on April 9, 2003 after a review of 180 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.

FDA 510(k) Submission Details - K023412

510(k) Number K023412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date April 09, 2003
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K023412.
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
K031905 · Actherm, Inc. · Jul 2003
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
K031556 · Vivant Medical, Inc. · Jun 2003
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
FLEXIBLE TIP THERMOMETER, MODEL 011206
K030673 · Global Treasure Industries , Ltd. · Apr 2003
STANDARD THERMOMETER
K030658 · Global Treasure Industries , Ltd. · Mar 2003
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
K030324 · Radiant Innovation, Inc. · Feb 2003
K023412 · THERMO BUDDY, MODELS TB-100, TB-110, TB-120
Download PDF FDA Summary Hubdic Co., Ltd.