Cleared Traditional

K213011 - Infrared Thermometer (model: E201)

K213011 is an FDA 510(k) clearance for Infrared Thermometer (model: E201), manufactured by Bioland Technology, Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K213011 · Bioland Technology, Ltd. · General Hospital
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Apr 2022
Decision
197d
Days
Class 2
Risk

K213011 is an FDA 510(k) clearance for the Infrared Thermometer (model: E201). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Bioland Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 5, 2022 after a review of 197 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 Bioland Technology, Ltd. devices

FDA 510(k) Submission Details - K213011

510(k) Number K213011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date April 05, 2022
Days to Decision 197 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
68d slower than avg
Panel avg: 129d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 372
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K213011.
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
K212346 · Shenzhen Pango Medical Electronics Co., Ltd. · May 2022
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
K212257 · Alicn Medical (Shenzhen), Inc. · May 2022
Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
K200946 · Taidoc Technology Corporation · Apr 2022
Digital thermometer, Model DT101, DT102
K213746 · Guangzhou Berrcom Medical Device Co., Ltd. · Apr 2022
Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
K210171 · Sichuan Youkede Medical Equipment Co.,Ltd · Mar 2022
Infrared Forehead Thermometer, model: HS-9802D
K213038 · Jiaxing Shangjia Intelligence Technology Co., Ltd. · Mar 2022