510(k) · Cleared
ClearedUri TX-100 Multichannel Thermocouple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uri Therm-X, Inc. · FLL Continuous Measurement Thermometer
Cleared on Oct 11, 1984 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Oct 11, 1984
- Review
- 44 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK843381 Uri TX-100 Multichannel ThermocoupleUri Therm-X, Inc. · 1984
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K843381 | Uri TX-100 Multichannel Thermocouple | Uri Therm-X, Inc. | 1984 | — |
| +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), 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? (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?
- 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 | — |
https://510kreport.com/device/K843381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K843381: Uri TX-100 Multichannel Thermocouple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843381
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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