Cleared Traditional

K082266 - DIGITAL CLINICAL THERMOMETER MODEL V9XX

K082266 is an FDA 510(k) clearance for DIGITAL CLINICAL THERMOMETER MODEL V9XX, manufactured by Amperor-Electronic(Sz) Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K082266 · Amperor-Electronic(Sz) Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2008
Decision
88d
Days
Class 2
Risk

K082266 is an FDA 510(k) clearance for the DIGITAL CLINICAL THERMOMETER MODEL V9XX. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Amperor-Electronic(Sz) Co., Ltd. (Shenzhen, Guandong, CN). The FDA issued a Cleared decision on November 7, 2008 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amperor-Electronic(Sz) Co., Ltd. devices

FDA 510(k) Submission Details - K082266

510(k) Number K082266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date November 07, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 399
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