Cleared Traditional

K023510 - TRUTEK SELECT MODEL TT-1001

K023510 is an FDA 510(k) clearance for TRUTEK SELECT MODEL TT-1001, manufactured by Trutek, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K023510 · Trutek, Inc. · General Hospital
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Feb 2003
Decision
106d
Days
Class 2
Risk

K023510 is an FDA 510(k) clearance for the TRUTEK SELECT MODEL TT-1001. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Trutek, Inc. (Crofton, US). The FDA issued a Cleared decision on February 4, 2003 after a review of 106 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 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 - K023510

510(k) Number K023510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date February 04, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 790
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K023510.
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
NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6
K030126 · Norm Pacific Automation Corp. · Feb 2003
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
K023500 · Innovatech, Inc. · Dec 2002
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
K023711 · Acute Ideas Co. , Ltd. · Nov 2002
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
K023538 · Medport, Inc. · Nov 2002

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K023510 · TRUTEK SELECT MODEL TT-1001
Download PDF Trutek, Inc.