510(k) · Cleared
ClearedCadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadi Scientific Pte.Ltd · FLL Continuous Measurement Thermometer
Cleared on Mar 11, 2009 as substantially equivalent to K033534 (Mini-Mitter Co., Inc., 2004) and 1 other predicate after a 133-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.
- Decided
- Mar 11, 2009
- Review
- 133 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914085 (1991). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 2 generations backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- 1 generation backK033534 VitalsenseMini-Mitter Co., Inc. · 2004
- This deviceK083185 Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG…Cadi Scientific Pte.Ltd · 2009
- Descendant · cites it directly · 4 of its ownK110015 Vitalsens, Aingeal, V-PodIntelesens Limited · 2011
- Descendant · 2 generations on · 1 of its ownK132407 Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK230298 Celsi MonitorHadleigh Health Technologies · 2023
- Descendant · 2 generations on · 0 of its ownK153275 Aingeal Activity SystemIntelesens, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK151835 Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011 · cites it directly4descendants
- K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014 · 2 generations on1descendant
- K230298Celsi MonitorHadleigh Health Technologies · 2023 · cites it directly0descendants
- K153275Aingeal Activity SystemIntelesens, Ltd. · 2016 · 2 generations on0descendants
- K151835Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −2 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| −1 | K033534 | Vitalsense | Mini-Mitter Co., Inc. | 2004 | — |
| 0 (this device) | K083185 | Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model… | Cadi Scientific Pte.Ltd | 2009 | — |
| +1 | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | — |
| +2 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | — |
| +1 | K230298 | Celsi Monitor | Hadleigh Health Technologies | 2023 | — |
| +2 | K153275 | Aingeal Activity System | Intelesens, Ltd. | 2016 | — |
| +3 | K151835 | Vital Signs Patch System | Lifewatch Technologies, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K033534 | VitalsenseSummary page 1…II (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K033534 VitalSense Integrated Mini Mitter Co., Inc. (now Physiological Monitoring… | 2004 |
| * | K003326 | Funet Amy Mama Body ThermometerSummary page 1…tegrated Mini Mitter Co., Inc. (now Physiological Monitoring Respironics) System K003326 Funai Amy Mama Wireless Funai Radio & Thermometer Monitor (Baby Communicati… | 2001 |
What descends from it? (6)
2 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K110015 (Intelesens Limited, 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K033534.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes. The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display…
Read the full statement (99 words)
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.
The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.
Warning: This equipment measures and reports abdominal surface temperature - where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083185: Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083185
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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