Cleared Traditional

K023711 - DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE

K023711 is an FDA 510(k) clearance for DIGITAL THERMOMETER CLASSIC TYPE AND FL..., manufactured by Acute Ideas Co. , Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K023711 · Acute Ideas Co. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
17d
Days
Class 2
Risk

K023711 is an FDA 510(k) clearance for the DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Acute Ideas Co. , Ltd. (Taipei, TW). The FDA issued a Cleared decision on November 21, 2002 after a review of 17 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 - K023711

510(k) Number K023711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2002
Decision Date November 21, 2002
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 681
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K023711.
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
TRUTEK SELECT MODEL TT-1001
K023510 · Trutek, Inc. · Feb 2003
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
K023500 · Innovatech, Inc. · Dec 2002
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
K023538 · Medport, Inc. · Nov 2002
TIMEX DIGITAL ORAL THERMOMETERS
K023069 · Medport, Inc. · Oct 2002
PHILIPS BABY THERMOMETER SET (SBC SC530)
K022542 · Philips Consumer Electronics · Aug 2002
K023711 · DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
Download PDF FDA Summary Acute Ideas Co. , Ltd.