Cleared Traditional

K233280 - SteadyTemp

K233280 is an FDA 510(k) clearance for SteadyTemp, manufactured by Steadysense GmbH. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K233280 · Steadysense GmbH · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K233280

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.

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 374
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