510(k) · Cleared
ClearedCirca S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circa Scientific, LLC · FLL Continuous Measurement Thermometer
Cleared on Dec 17, 2021 as substantially equivalent to K192210 (Fiab Spa, 2019) after a 618-day review. Its family tree reaches back 5 generations to 1986. 1 later device descends from it.
- Decided
- Dec 17, 2021
- Review
- 618 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K863646 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK863646 Esophageal Rectal Temperature ProbeRespiratory Support Products, Inc. · 1986
- 4 generations backK112376 S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2011
- 3 generations backK123361 Esotest Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2013
- 2 generations backK180047 ESOTEST MULTI Esophageal Temperature Probe and Temperature…Fiab Spa · 2018
- 1 generation backK192210 ESOTEST MULTI Esophageal Temperature Probe and Temperature…Fiab Spa · 2019
- This deviceK200943 Circa S-Cath M Esophageal Temperature Probe and Temperature…Circa Scientific, LLC · 2021
- Descendant · cites it directly · 0 of its ownK222311 CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature…Circa Scientific, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K863646 | Esophageal Rectal Temperature Probe | Respiratory Support Products, Inc. | 1986 | — |
| −4 | K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | 2011 | — |
| −3 | K123361 | Esotest Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2013 | — |
| −2 | K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2018 | — |
| −1 | K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2019 | — |
| 0 (this device) | K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemSummary page 4…meter (21 CFR 880.2910) Regulatory Class: II Product Code(s): FLL, IKD Predicate Device: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, K192210 Reference Device: S-Cath Esophageal Temperature Probe and Temperature Monitoring Probe, K112376 III. DEVICE DESCRIPTION… | 2019 |
| † | K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring System | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | 2023 | 0 |
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 35 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K222311 (Circa Scientific, Inc., 2023) has gone furthest, with 0 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. 2021, 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 CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe. The role of esophageal temperature monitoring using this device in…
Read the full statement (106 words)
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200943: Circa S-Cath M 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/K200943
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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