Cleared Traditional

K011291 - TEMPORALSCANNER THERMOMETER, SENSORTOUCH

K011291 is an FDA 510(k) clearance for TEMPORALSCANNER THERMOMETER, manufactured by Exergen Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K011291 · Exergen Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
76d
Days
Class 2
Risk

K011291 is an FDA 510(k) clearance for the TEMPORALSCANNER THERMOMETER, SENSORTOUCH. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Exergen Corp. (Washington, US). The FDA issued a Cleared decision on July 12, 2001 after a review of 76 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 - K011291

510(k) Number K011291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2001
Decision Date July 12, 2001
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K011291.
INFARED EAR THERMOMETER, MODEL TH8 SERIES
K011059 · Radiant Innovation, Inc. · Sep 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · Avita Corporation · Sep 2001
M5T INSTANT FEVER THERMOMETER
K012217 · Medisim, Ltd. · Aug 2001
EAR THERMOMETER, MODELS ST613C AND ST613F
K011254 · Mesure Technology · Jul 2001
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
K010235 · Oriental System Technology, Inc. · Jul 2001
NPAC EAR THERMOMETER MODEL TD 402
K011704 · Norm Pacific Automation Corp. · Jun 2001
K011291 · TEMPORALSCANNER THERMOMETER, SENSORTOUCH
Download PDF FDA Summary Exergen Corp.