Cleared Abbreviated

K200710 - Infrared PT2L Digital No-Touch Thermometer

K200710 is the FDA 510(k) clearance for Infrared PT2L Digital No-Touch Thermometer by Andon Health Co, Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Abbreviated 510(k) pathway after a 197-day FDA review.

K200710 · Andon Health Co, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2020
Decision
197d
Days
Class 2
Risk

K200710 is an FDA 510(k) clearance for the Infrared PT2L Digital No-Touch Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on October 1, 2020 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K200710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2020
Decision Date October 01, 2020
Days to Decision 197 days
Submission Type Abbreviated
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
Standards-based clearance path.

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 Peers - FLL Continuous Measurement Thermometer

All 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K200710.
Infrared ear and forehead thermometer, model YI-100
K201843 · Wenzhou Yosun Medical Technology Co.,Ltd · Oct 2020
Infrared Thermometer
K200802 · Shenzhen Urion Technology Co., Ltd. · Oct 2020
Infrared Thermometer Model E127
K201161 · Bioland Technology, Ltd. · Oct 2020
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 2020
Disposable Temperature Probe
K193625 · Shenzhen Changke Connect Electronics Co., Ltd. · Jul 2020
Infrared Thermometer Model Number RN-50A,RN-50B
K200578 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Jul 2020