Cleared Special

K030126 - 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 is an FDA 510(k) clearance for NPAC MULTI-USE EAR THERMOMETER, manufactured by Norm Pacific Automation Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 24-day FDA review.

K030126 · Norm Pacific Automation Corp. · General Hospital
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Feb 2003
Decision
24d
Days
Class 2
Risk

K030126 is an FDA 510(k) clearance for the NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Norm Pacific Automation Corp. (Hsin-Chu, TW). The FDA issued a Cleared decision on February 7, 2003 after a review of 24 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 - K030126

510(k) Number K030126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2003
Decision Date February 07, 2003
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
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 K030126.
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
K030324 · Radiant Innovation, Inc. · Feb 2003
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
K030299 · Oriental System Technology, Inc. · Feb 2003
JASUN, MODELS DT-01F AND DT-11F
K030361 · Hangzhou Hua'An Medical & Health Instruments Co., · 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
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
K023711 · Acute Ideas Co. , Ltd. · Nov 2002
K030126 · 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
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