Cleared Special

K051835 - NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702

K051835 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 79-day FDA review.

K051835 · Norm Pacific Automation Corp. · General Hospital
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Sep 2005
Decision
79d
Days
Class 2
Risk

K051835 is an FDA 510(k) clearance for the NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702. 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 September 23, 2005 after a review of 79 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 - K051835

510(k) Number K051835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2005
Decision Date September 23, 2005
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 K051835.
BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
K060006 · Braun GmbH · Jan 2006
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER
K051566 · Proton Healthcare , Ltd. · Jan 2006
INFRARED THERMOMETER, FDIR-V1
K052849 · Famidoc Technology Co., Ltd. · Oct 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
K051269 · Radiant Innovation, Inc. · Sep 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2005
K051835 · NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
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