Cleared Traditional

K042906 - AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101

K042906 is an FDA 510(k) clearance for AMPLIFE DIGITAL INFRARED EAR THERMOMETER, manufactured by Amplife Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K042906 · Amplife Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
29d
Days
Class 2
Risk

K042906 is an FDA 510(k) clearance for the AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Amplife Corporation (Great Neck, US). The FDA issued a Cleared decision on November 19, 2004 after a review of 29 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.

FDA 510(k) Submission Details - K042906

510(k) Number K042906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2004
Decision Date November 19, 2004
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE JR.

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 739
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K042906.
EAR THERMOMETER, MODEL WL-320X
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MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110 · Microlife Intellectual Property GmbH · Dec 2004
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
K042653 · Pack & Proper Co., Ltd. · Nov 2004
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
K042627 · Mesure Technology Co., Ltd. · Oct 2004
AMPLIFE DIGITAL CLINICAL THERMOMETER
K042575 · Amplife Corporation · Sep 2004
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
K040377 · Radiant Innovation, Inc. · Sep 2004

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K042906 · AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
Download PDF FDA Summary Amplife Corporation