Cleared Traditional

K041692 - INFRARED EAR THERMOMETER

K041692 is the FDA 510(k) clearance for INFRARED EAR THERMOMETER by Hangzhou Hua'An Medical & Health Instruments Co.,. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K041692 · Hangzhou Hua'An Medical & Health Instruments Co., · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
83d
Days
Class 2
Risk

K041692 is an FDA 510(k) clearance for the INFRARED EAR THERMOMETER, ET-100 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Hangzhou Hua'An Medical & Health Instruments Co., (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on September 13, 2004 after a review of 83 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 Hangzhou Hua'An Medical & Health Instruments Co., devices

Submission Details

510(k) Number K041692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2004
Decision Date September 13, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
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 Peers - FLL Continuous Measurement Thermometer

All 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K041692.
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · Microlife Intellectual Property GmbH · May 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · Ge Healthcare · Apr 2005
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110 · Microlife Intellectual Property GmbH · Dec 2004
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820 · Microlife Intellectual Property GmbH · Feb 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023 · Microlife Intellectual Property GmbH · Jan 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817 · Microlife Intellectual Property GmbH · Jan 2004