Cleared Traditional

K060649 - GENIUS 2 INFRARED TYMPANIC ELECTRONIC T...

K060649 is an FDA 510(k) clearance for GENIUS 2 INFRARED TYMPANIC ELECTRONIC T..., manufactured by Tyco Healthcare Group LP. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K060649 · Tyco Healthcare Group LP · General Hospital
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May 2006
Decision
70d
Days
Class 2
Risk

K060649 is an FDA 510(k) clearance for the GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Tyco Healthcare Group LP (Mansfield, US). The FDA issued a Cleared decision on May 22, 2006 after a review of 70 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 Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K060649

510(k) Number K060649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2006
Decision Date May 22, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
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 373
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K060649.
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K061800 · Taidoc Technology Corporation · Jul 2006
K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
K060240 · K-Jump Health Co., Ltd. · May 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173 · ACON Laboratories, Inc. · Mar 2006
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005