Cleared Special

K122912 - DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)

K122912 is an FDA 510(k) clearance for DIGITAL THERMOMETER (WITH DISPOSABLE TH..., manufactured by Hangzhou Hua'An Medical & Health Instruments Co.,. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 47-day FDA review.

K122912 · Hangzhou Hua'An Medical & Health Instruments Co., · General Hospital
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Nov 2012
Decision
47d
Days
Class 2
Risk

K122912 is an FDA 510(k) clearance for the DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Hangzhou Hua'An Medical & Health Instruments Co., (Wuchang, Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on November 7, 2012 after a review of 47 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.

View all Hangzhou Hua'An Medical & Health Instruments Co., devices

FDA 510(k) Submission Details - K122912

510(k) Number K122912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date November 07, 2012
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 527
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K122912.
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