510(k) · Cleared
ClearedDisposable Temperature Probes / Sensors and Interconnect Instrument Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starboard Medical, LLC · FLL Continuous Measurement Thermometer
Cleared on Aug 11, 2011 as substantially equivalent to K864195 (Respiratory Support Products, Inc., 1986) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Aug 11, 2011
- Review
- 97 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864195 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864195 Surface Skin Temp Probe W/Thermocouple Type TRespiratory Support Products, Inc. · 1986 · Recalled
- This deviceK111282 Disposable Temperature Probes / Sensors and Interconnect Instrument…Starboard Medical, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864195 | Surface Skin Temp Probe W/Thermocouple Type T | Respiratory Support Products, Inc. | 1986 | 2 |
| 0 (this device) | K111282 | Disposable Temperature Probes / Sensors and Interconnect Instrument Cables | Starboard Medical, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K864195 | Surface Skin Temp Probe W/Thermocouple Type TSummary page 1…el: General Hospital Predicate Device: The following devices have been identified as predicate devices: SMITHS LEVEL 1 Skin Temperature Sensor - K864195 SMITHS LEVEL 1 Tympanic Temperature Sensor - K873205 Description of device: The Starboard Medical tempe… | 1986 |
| * | K873205 | Tympanic Temperature SensorSummary page 1…evices have been identified as predicate devices: SMITHS LEVEL 1 Skin Temperature Sensor - K864195 SMITHS LEVEL 1 Tympanic Temperature Sensor - K873205 Description of device: The Starboard Medical temperature sensors are intended for use in clinical situations where… | 1988 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Starboard Medical Skin temperature sensor is indicated for continuous patient temperature monitoring when the skin placement site is clinically recommended. The sensor is designed for placement on the surface of the skin.
The Starboard Medical Tympanic Temperature sensor is indicated for continuous monitoring of patient temperature when the ear canal placement site is clinically recommended. The probe is designed for insertion into the ear canal in the proximity of the Tympanic membrane.
The instwument cables are indicated for interconnecting the disposable temperature sensor or probe with the monitoring instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111282: Disposable Temperature Probes / Sensors and Interconnect Instrument Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111282
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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