Cleared Special

K030299 - TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX

K030299 is an FDA 510(k) clearance for TEMPTELLER INFARED EAR THERMOMETERS, manufactured by Oriental System Technology, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 27-day FDA review.

K030299 · Oriental System Technology, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
27d
Days
Class 2
Risk

K030299 is an FDA 510(k) clearance for the TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Oriental System Technology, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 25, 2003 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030299

510(k) Number K030299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2003
Decision Date February 25, 2003
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 739
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K030299.
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K030299 · TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
Download PDF FDA Summary Oriental System Techn…