Cleared Traditional

Ear Thermometer, Model ET005, ET008, ET009 (K213084) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213084 · Guangzhou Berrcom Medical Device Co., Ltd. · General Hospital
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Feb 2022
Decision
155d
Days
Class 2
Risk

K213084 is an FDA 510(k) clearance for the Ear Thermometer, Model ET005, ET008, ET009. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Guangzhou Berrcom Medical Device Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 25, 2022 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Guangzhou Berrcom Medical Device Co., Ltd. devices

Submission Details

510(k) Number K213084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2021
Decision Date February 25, 2022
Days to Decision 155 days
Submission Type Traditional
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
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Yoyo Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K213084.
Infrared Forehead Thermometer, model: HS-9802D
K213038 · Jiaxing Shangjia Intelligence Technology Co., Ltd. · Mar 2022
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
K211776 · Microlife Intellectual Property GmbH · Mar 2022
Sterile Disposable Temperature Probe
K212945 · Shenzhen Envisen Industry Co., Ltd. · Mar 2022
Ear Thermometer, Model ET001
K213079 · Guangzhou Berrcom Medical Device Co., Ltd. · Feb 2022
iHealth infrared Ear thermometer PT5
K212598 · Andon Health Co, Ltd. · Jan 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · Guangzhou Berrcom Medical Device Co., Ltd. · Jan 2022