510(k) · Cleared
ClearedTurbo Temp Trio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · FLL Continuous Measurement Thermometer
Cleared on Feb 16, 2005 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK050230 Turbo Temp TrioCardinal Health, Alaris Products · 2005
- Descendant · cites it directly · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
- Descendant · 2 generations on · 3 of its ownK151071 SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas · 2015
- Descendant · 2 generations on · 3 of its ownK133810 VC150 Vital Signs MonitorInnokas Yhtyma · 2014 · Recalled
- Descendant · 3 generations on · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 2 of its ownK171751 SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for…Capsule Technologie Sas · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · cites it directly11descendants
- K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas · 2015 · 2 generations on3descendants
- K133810VC150 Vital Signs MonitorInnokas Yhtyma · 2014 · 2 generations on3descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 3 generations on2descendants
- K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050230 | Turbo Temp Trio | Cardinal Health, Alaris Products | 2005 | — |
| +1 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
| +2 | K151071 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2015 | — |
| +2 | K133810 | VC150 Vital Signs Monitor | Innokas Yhtyma | 2014 | 3 |
| +3 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +3 | K171751 | SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot… | Capsule Technologie Sas | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (13)
See all 132 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, K102426 (Ge Medical Systems Information Technologies, 2010) has gone furthest, with 11 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/K050230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050230: Turbo Temp Trio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050230
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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