510(k) · Cleared
ClearedEsotest Esophageal Temperature Probe and Temperature Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiab Spa · FLL Continuous Measurement Thermometer
Cleared on Feb 27, 2013 as substantially equivalent to K112376 (Circa Scientific, LLC, 2011) after a 119-day review. Its family tree reaches back 2 generations to 1986. 6 later devices descend from it.
- Decided
- Feb 27, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863646 (1986). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK863646 Esophageal Rectal Temperature ProbeRespiratory Support Products, Inc. · 1986
- 1 generation backK112376 S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2011
- This deviceK123361 Esotest Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2013
- Descendant · cites it directly · 3 of its ownK180047 ESOTEST MULTI Esophageal Temperature Probe and Temperature…Fiab Spa · 2018
- Descendant · 2 generations on · 2 of its ownK192210 ESOTEST MULTI Esophageal Temperature Probe and Temperature…Fiab Spa · 2019
- Descendant · 3 generations on · 1 of its ownK200943 Circa S-Cath M Esophageal Temperature Probe and Temperature…Circa Scientific, LLC · 2021
- Descendant · cites it directly · 1 of its ownK152402 IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit…Securus,Inc · 2016
- Descendant · 4 generations on · 0 of its ownK222311 CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature…Circa Scientific, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180047ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2018 · cites it directly3descendants
- K192210ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2019 · 2 generations on2descendants
- K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2021 · 3 generations on1descendant
- K152402IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient…Securus,Inc · 2016 · cites it directly1descendant
- K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863646 | Esophageal Rectal Temperature Probe | Respiratory Support Products, Inc. | 1986 | — |
| −1 | K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | 2011 | — |
| 0 (this device) | K123361 | Esotest Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2013 | — |
| +1 | K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2018 | — |
| +2 | K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2019 | — |
| +3 | K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | 2021 | — |
| +1 | K152402 | IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS… | Securus,Inc | 2016 | — |
| +4 | K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring System | 2011 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 3 companies; a new generation was cleared every 24.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180047 (Fiab Spa, 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
ESOTEST Probe
Esotest probe is intended for continuous esophageal temperature monitomig,
ESOTEST Monitor
Esotest monitor is intended for display continuous temperature measurement (0 C) from 3 sensors temperature probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123361: Esotest Esophageal Temperature Probe and Temperature Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123361
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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