Cleared Traditional

K042575 - AMPLIFE DIGITAL CLINICAL THERMOMETER

K042575 is an FDA 510(k) clearance for AMPLIFE DIGITAL CLINICAL 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 8-day FDA review.

K042575 · Amplife Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
8d
Days
Class 2
Risk

K042575 is an FDA 510(k) clearance for the AMPLIFE DIGITAL CLINICAL THERMOMETER. 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 September 30, 2004 after a review of 8 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 - K042575

510(k) Number K042575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date September 30, 2004
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
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.
NEIL E DEVINE

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 K042575.
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
K042653 · Pack & Proper Co., Ltd. · Nov 2004
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
K042906 · Amplife Corporation · Nov 2004
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
K042627 · Mesure Technology Co., Ltd. · Oct 2004
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
K040377 · Radiant Innovation, Inc. · Sep 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · Hangzhou Hua'An Medical & Health Instruments Co., · Sep 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
K041694 · Hangzhou Hua'An Medical & Health Instruments Co., · 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.

K042575 · AMPLIFE DIGITAL CLINICAL THERMOMETER
Download PDF FDA Summary Amplife Corporation