510(k) · Cleared
ClearedIvac Model 2080 Electronic Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Y · FLL Continuous Measurement Thermometer
Cleared on Feb 12, 1986 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 12, 1986
- Review
- 8 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK860436 Ivac Model 2080 Electronic ThermometerY · 1986
- Descendant · cites it directly · 2 of its ownK072516 Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group · 2007
- Descendant · 2 generations on · 1 of its ownK161909 IQvitals ZoneMidmark Corporation · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK253196 Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200…Midmark Corporation · 2026
- Descendant · cites it directly · 0 of its ownK070342 Clinical Electronic Thermometer, Models TP11403 Through TP11413American I.V. Products, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK964851 Entracare Thermomter Model 1000Entracare Corp. · 1997
Most influential descendants
Showing 5 of 5 · See all- K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group · 2007 · cites it directly2descendants
- K161909IQvitals ZoneMidmark Corporation · 2016 · 2 generations on1descendant
- K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026 · 3 generations on0descendants
- K070342Clinical Electronic Thermometer, Models TP11403 Through TP11413American I.V. Products, Inc. · 2007 · cites it directly0descendants
- K964851Entracare Thermomter Model 1000Entracare Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860436 | Ivac Model 2080 Electronic Thermometer | Y | 1986 | — |
| +1 | K072516 | Midmark Diagnostics Iqmark Vital Signs Monitor | Midmark Diagnostics Group | 2007 | — |
| +2 | K161909 | IQvitals Zone | Midmark Corporation | 2016 | 4 |
| +3 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300… | Midmark Corporation | 2026 | — |
| +1 | K070342 | Clinical Electronic Thermometer, Models TP11403 Through TP11413 | American I.V. Products, Inc. | 2007 | — |
| +1 | K964851 | Entracare Thermomter Model 1000 | Entracare Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 2 | 0 |
| 2016 | 1 | 0 |
| 2026 | 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? (5)
3 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, K072516 (Midmark Diagnostics Group, 2007) has gone furthest, with 2 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/K860436 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860436: Ivac Model 2080 Electronic Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860436
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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