Cleared Traditional

K023069 - TIMEX DIGITAL ORAL THERMOMETERS

Also marketed or referenced as:
TIMEX ACCUCURVE ORAL THERMOMETER

K023069 is an FDA 510(k) clearance for TIMEX DIGITAL ORAL THERMOMETERS, manufactured by Medport, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K023069 · Medport, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
32d
Days
Class 2
Risk

K023069 is an FDA 510(k) clearance for the TIMEX DIGITAL ORAL THERMOMETERS. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Medport, Inc. (Beverly, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 32 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 - K023069

510(k) Number K023069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2002
Decision Date October 18, 2002
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 738
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K023069.
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
PHILIPS BABY THERMOMETER SET (SBC SC530)
K022542 · Philips Consumer Electronics · Aug 2002
EASYTEM EAR THERMOMETER, MODEL BT-020
K020520 · Metatech Co., Ltd. · Aug 2002
E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
K021753 · E-Care Technology Corporation · Aug 2002
K023069 · TIMEX DIGITAL ORAL THERMOMETERS
Download PDF FDA Summary Medport, Inc.