Cleared Traditional

K033790 - THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033790 · Tecnimed S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
182d
Days
Class 2
Risk

K033790 is an FDA 510(k) clearance for the THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Tecnimed S.R.L. (Great Neck, US). The FDA issued a Cleared decision on June 3, 2004 after a review of 182 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecnimed S.R.L. devices

Submission Details

510(k) Number K033790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date June 03, 2004
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 128d · This submission: 182d
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 796
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K033790.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
K251160 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2026
Ear Thermometer (EAR-E101)
K250470 · Shenzhen AOJ Medical Technology Co., Ltd. · Jun 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · Shenzhen Medke Technology Co., Ltd. · Jun 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2025
Infrared Thermometer
K243082 · Guangzhou Daxin Health Technology Co., Ltd. · Apr 2025
AION TempShield™
K250401 · Aion Biosystems, Inc. · Mar 2025