510(k) · Cleared
ClearedEndocare Electornic Thermometer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocare, Inc. · FLL Continuous Measurement Thermometer
Cleared on Aug 15, 1996 as substantially equivalent to K830592 (Electromedics, Inc., 1983) after a 128-day review. Its family tree reaches back 1 generation to 1983. 21 later devices descend from it.
- Decided
- Aug 15, 1996
- Review
- 128 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830592 (1983). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830592 Dispos. Type T Thermocouple Temp.ProbeElectromedics, Inc. · 1983
- This deviceK961365 Endocare Electornic Thermometer SystemEndocare, Inc. · 1996
- Descendant · cites it directly · 20 of its ownK031556 Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 2003
- Descendant · 2 generations on · 15 of its ownK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- Descendant · 3 generations on · 11 of its ownK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- Descendant · 4 generations on · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- Descendant · 5 generations on · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K031556Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 2003 · cites it directly20descendants
- K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006 · 2 generations on15descendants
- K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008 · 3 generations on11descendants
- K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · 4 generations on10descendants
- K103014Miradry SystemMiramar Labs, Inc. · 2011 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830592 | Dispos. Type T Thermocouple Temp.Probe | Electromedics, Inc. | 1983 | — |
| 0 (this device) | K961365 | Endocare Electornic Thermometer System | Endocare, Inc. | 1996 | — |
| +1 | K031556 | Vivatherm Themperature Measurement System | Vivant Medical, Inc. | 2003 | — |
| +2 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| +3 | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| +4 | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
| +5 | K103014 | Miradry System | Miramar Labs, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K830592 | Dispos. Type T Thermocouple Temp.ProbeSummary page 1…nitoring System. The Bailey BAT-8 clinical monitoring thermometers ( Pre-Medical Device Amendments of 1976) and the Electromedics TM147T Temperature Monitoring System{K#830592A) have been granted market clearance by the FDA . | 1983 |
| * | — | Bailey BAT-8 clinical monitoring thermometers Named without a submission number |
What descends from it? (21)
See all 212 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?
- Its one ancestor has no recall.
- Of its descendants, K031556 (Vivant Medical, Inc., 2003) has gone furthest, with 20 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 | — |
What is it indicated for?
The Endocare Electronic Thermometer System are designed for use in General Surgery, Urology, and Gynecology to monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961365: Endocare Electornic Thermometer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961365
Report an extraction error
Are you the manufacturer?
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