Cleared Traditional

K081445 - FORA COMFORTSCAN EAR THERMOMETER

Also marketed or referenced as:
TD-1261B

K081445 is the FDA 510(k) clearance for FORA COMFORTSCAN EAR THERMOMETER by Taidoc Technology Corporation. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K081445 · Taidoc Technology Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
81d
Days
Class 2
Risk

K081445 is an FDA 510(k) clearance for the FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on August 11, 2008 after a review of 81 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.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K081445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date August 11, 2008
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K081445.
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395 · Taidoc Technology Corporation · Mar 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · Taidoc Technology Corporation · Feb 2009
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
K083299 · Taidoc Technology Corporation · Dec 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · Microlife Intellectual Property GmbH · Sep 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · ACON Laboratories, Inc. · Feb 2007