510(k) · Cleared
ClearedSkin Sensor Probe, General Purpose Probe, Tympanic Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truer Medical, Inc. · FLL Continuous Measurement Thermometer
Cleared on Nov 18, 2010 after a 198-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 18, 2010
- Review
- 198 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient Skin orobe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. T'he skin temperature probe is designed for use…
Read the full statement (243 words)
The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient
Skin orobe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. T'he skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
OP Probes (OP 9400. OP 9700 and OP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Tvmvanic Probe (T? 400 and TP' 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101244: Skin Sensor Probe, General Purpose Probe, Tympanic Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101244
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026