Cleared Abbreviated

K212598 - iHealth infrared Ear thermometer PT5

K212598 is the FDA 510(k) clearance for iHealth infrared Ear thermometer PT5 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 165-day FDA review.

K212598 · Andon Health Co, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
165d
Days
Class 2
Risk

K212598 is an FDA 510(k) clearance for the iHealth infrared Ear thermometer PT5. 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 January 28, 2022 after a review of 165 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 K212598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2021
Decision Date January 28, 2022
Days to Decision 165 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
36d slower than avg
Panel avg: 129d · This submission: 165d
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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K212598.
Sterile Disposable Temperature Probe
K212945 · Shenzhen Envisen Industry Co., Ltd. · Mar 2022
Ear Thermometer, Model ET005, ET008, ET009
K213084 · Guangzhou Berrcom Medical Device Co., Ltd. · Feb 2022
Ear Thermometer, Model ET001
K213079 · Guangzhou Berrcom Medical Device Co., Ltd. · Feb 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · Guangzhou Berrcom Medical Device Co., Ltd. · Jan 2022
Infrared Thermometer
K211752 · Beijing Choice Electronic Technology Co., Ltd. · Jan 2022
Infrared Thermometer
K210564 · Alicn Medical (Shenzhen), Inc. · Jan 2022