510(k) · Cleared
ClearedEsophageal Rectal Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respiratory Support Products, Inc. · FLL Continuous Measurement Thermometer
Cleared on Nov 25, 1986 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Nov 25, 1986
- Review
- 68 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK863646 Esophageal Rectal Temperature ProbeRespiratory Support Products, Inc. · 1986
- Descendant · cites it directly · 7 of its ownK112376 S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2011
- Descendant · 2 generations on · 6 of its ownK123361 Esotest Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2013
- Descendant · 3 generations on · 3 of its ownK180047 ESOTEST MULTI Esophageal Temperature Probe and Temperature…Fiab Spa · 2018
- Descendant · 4 generations on · 2 of its ownK192210 ESOTEST MULTI Esophageal Temperature Probe and Temperature…Fiab Spa · 2019
- Descendant · 5 generations on · 1 of its ownK200943 Circa S-Cath M Esophageal Temperature Probe and Temperature…Circa Scientific, LLC · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112376S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2011 · cites it directly7descendants
- K123361Esotest Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2013 · 2 generations on6descendants
- K180047ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2018 · 3 generations on3descendants
- K192210ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2019 · 4 generations on2descendants
- K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K123361 | Esotest Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2013 | — |
| +3 | K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2018 | — |
| +4 | K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | 2019 | — |
| +5 | K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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?
- Of its descendants, K112376 (Circa Scientific, LLC, 2011) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/K863646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K863646: Esophageal Rectal Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863646
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026