Cleared Traditional Expedited

K033534 - VITALSENSE

K033534 is an FDA 510(k) clearance for VITALSENSE, manufactured by Mini-Mitter Co., Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K033534 · Mini-Mitter Co., Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
164d
Days
Class 2
Risk

K033534 is an FDA 510(k) clearance for the VITALSENSE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mini-Mitter Co., Inc. (Bend, US). The FDA issued a Cleared decision on April 22, 2004 after a review of 164 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.

FDA 510(k) Submission Details - K033534

510(k) Number K033534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date April 22, 2004
Days to Decision 164 days
Submission Type Traditional
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
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FLL Continuous Measurement Thermometer

All 695
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K033534.
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K033790 · Tecnimed S.R.L. · Jun 2004
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
K041056 · Mesure Technology Co., Ltd. · May 2004
EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
K033077 · Metatech Co., Ltd. · Apr 2004
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820 · Microlife Intellectual Property GmbH · Feb 2004
IR FOREHEAD THERMOMETER, MODEL HV-T36
K032612 · Oriental Inspiration, Ltd. · Feb 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023 · Microlife Intellectual Property GmbH · Jan 2004
K033534 · VITALSENSE
Download PDF FDA Summary Mini-Mitter Co., Inc.