Cleared Special

K112116 - DIGITAL CLINICAL THERMOMETER MODEL V901US

K112116 is an FDA 510(k) clearance for DIGITAL CLINICAL THERMOMETER MODEL V901US, manufactured by Amperor-Electronic(Sz) Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 71-day FDA review.

K112116 · Amperor-Electronic(Sz) Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
71d
Days
Class 2
Risk

K112116 is an FDA 510(k) clearance for the DIGITAL CLINICAL THERMOMETER MODEL V901US. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Amperor-Electronic(Sz) Co., Ltd. (Southborough, US). The FDA issued a Cleared decision on October 4, 2011 after a review of 71 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 - K112116

510(k) Number K112116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2011
Decision Date October 04, 2011
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 681
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K112116.
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K112116 · DIGITAL CLINICAL THERMOMETER MODEL V901US
Download PDF FDA Summary Amperor-Electronic(Sz…