510(k) · Cleared
ClearedTemperature Probe, Affinity Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · FLL Continuous Measurement Thermometer
Cleared on May 20, 2016 as substantially equivalent to K100645 (Medtronic, Inc., 2012) and 1 other predicate after a 126-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 20, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K936003 (1994). 8 ancestors in all, the oldest K831528 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK936003 Affinity CVRAvecor Cardiovascular, Inc. · 1994 · Recalled
- 2 generations backK021287 Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TTMedtronic Perfusion Systems · 2002 · Recalled
- 1 generation backK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- This deviceK160091 Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936003 | Affinity CVR | Avecor Cardiovascular, Inc. | 1994 | 3 |
| −2 | K021287 | Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT | Medtronic Perfusion Systems | 2002 | 1 |
| −1 | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| 0 (this device) | K160091 | Temperature Probe, Affinity Temperature Probe | Medtronic, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceSummary page 4…: Clinical Electronic Thermometer Regulation Number: 880.2910 Product Code: FLL Product Classification: Class II Predicate Device K100645 Affinity Temperature Probe Reference Device K831528 Temperature Probe Devi… | 2012 |
| * | K831528 | Model TP Thermistor ProbeSummary page 4…880.2910 Product Code: FLL Product Classification: Class II Predicate Device K100645 Affinity Temperature Probe Reference Device K831528 Temperature Probe Device Description The temperature probe devices are intended for use with t… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K100645.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 temperature probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's instructions for use. The temperature probe is designed for use with a YSI tele-thermometer to monitor and display temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160091: Temperature Probe, Affinity 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/K160091
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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