510(k) · Cleared
ClearedSteadyTemp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steadysense GmbH · FLL Continuous Measurement Thermometer
Cleared on Jun 21, 2024 as substantially equivalent to K201977 (Blue Spark Technologies, Inc., 2020) after a 266-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 21, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003326 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
- 4 generations backK023956 Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F…Mesure Technology Co., Ltd. · 2004
- 3 generations backK063542 Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd. · 2007
- 2 generations backK143267 TempTraq TT-100Blue Spark Technologies, Inc. · 2015
- 1 generation backK201977 TempTraqBlue Spark Technologies, Inc. · 2020
- This deviceK233280 SteadyTempSteadysense GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003326 | Funet Amy Mama Body Thermometer | Funai Radio & Communications Corp. | 2001 | — |
| −4 | K023956 | Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F | Mesure Technology Co., Ltd. | 2004 | — |
| −3 | K063542 | Wireless Temperature Monitor / Models ST323C and ST323F. | Mesure Technology Co., Ltd. | 2007 | — |
| −2 | K143267 | TempTraq TT-100 | Blue Spark Technologies, Inc. | 2015 | — |
| −1 | K201977 | TempTraq | Blue Spark Technologies, Inc. | 2020 | — |
| 0 (this device) | K233280 | SteadyTemp | Steadysense GmbH | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201977 | TempTraqSummary page 5…These differences do not impact safety or effectiveness. Name of Device: TempTraq, Model: TT-100, TT-200, TT-300 Predicate submission number: K201977 Regulation Number: 880.2910 Product Code: FLL IV. DEVICE DESCRIPTION Steady… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The SteadyTemp system is a wireless thermometer intended to provide precise body temperature for users of all ages. The SteadyTemp system comprises a single-use temperature measuring sensor, the SteadySense Patch, and the SteadyTemp application. SteadySense Patch measures and stores axillary skin temperature data up to 10 days. The typical application duration when using the system is 7 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233280: SteadyTemp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026