Cleared Traditional

SteadyTemp (K233280) - FDA 510(k) Clearance

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

K233280 · Steadysense GmbH · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
266d
Days
Class 2
Risk

K233280 is an FDA 510(k) clearance for the SteadyTemp. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Steadysense GmbH (Seiersberg Pirka, AT). The FDA issued a Cleared decision on June 21, 2024 after a review of 266 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 Steadysense GmbH devices

Submission Details

510(k) Number K233280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date June 21, 2024
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K233280.
FMT Disposable and Autoclavable Temperature Probes
K240223 · Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi · Oct 2024
Aulisa Temperature Module (TM0002)
K240220 · Taiwan Aulisa Medical Devices Technologies, Inc. · Sep 2024
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
K240077 · Covidien · Aug 2024
Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
K240648 · Radiant Innovation, Inc. · Jun 2024
Medical electronic thermometer (FC01, FC02)
K240109 · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Apr 2024
Wireless Smart Thermometer
K233192 · Famidoc Technology Company Limited · Apr 2024