510(k) · Cleared
ClearedVitalsense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mini-Mitter Co., Inc. · FLL Continuous Measurement Thermometer
Cleared on Apr 22, 2004 as substantially equivalent to K991045 (Mini-Mitter Co., Inc., 1999) after a 164-day review. Its family tree reaches back 2 generations to 1991. 10 later devices descend from it.
- Decided
- Apr 22, 2004
- Review
- 164 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914085 (1991). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 1 generation backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- This deviceK033534 VitalsenseMini-Mitter Co., Inc. · 2004
- Descendant · cites it directly · 6 of its ownK083185 Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG…Cadi Scientific Pte.Ltd · 2009
- Descendant · 2 generations on · 4 of its ownK110015 Vitalsens, Aingeal, V-PodIntelesens Limited · 2011
- Descendant · 3 generations on · 1 of its ownK132407 Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK102499 DuofertilityCambridge Temperature Concepts, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK230298 Celsi MonitorHadleigh Health Technologies · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K083185Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1Cadi Scientific Pte.Ltd · 2009 · cites it directly6descendants
- K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011 · 2 generations on4descendants
- K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014 · 3 generations on1descendant
- K102499DuofertilityCambridge Temperature Concepts, Ltd. · 2011 · cites it directly1descendant
- K230298Celsi MonitorHadleigh Health Technologies · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −1 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| 0 (this device) | K033534 | Vitalsense | Mini-Mitter Co., Inc. | 2004 | — |
| +1 | K083185 | Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model… | Cadi Scientific Pte.Ltd | 2009 | — |
| +2 | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | — |
| +3 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | — |
| +1 | K102499 | Duofertility | Cambridge Temperature Concepts, Ltd. | 2011 | — |
| +2 | K230298 | Celsi Monitor | Hadleigh Health Technologies | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K991045 | Mini-Logger Series 2000Summary page 1…GWK 11.1.3 Identification of predicate device Mini-Logger Series 2000, Physiological Data Logging Device 510(k) Number: K991045 Page 28 Mini Mitter Co, Inc.… | 1999 |
What descends from it? (10)
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083185 (Cadi Scientific Pte.Ltd, 2009) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K991045.
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 | — |
What is it indicated for?
VitalSense®can be used in any setting where physiological body core and skin temperature are used to further the understanding of body function. The device can be used for simultaneous assessment of core body temperature, dermal surface temperature, or ambient temperatures that require logging of data over time with subsequent conversion, display, and analysis of the aforementioned parameters. VitalSense® may be used in any instance where quantifiable analysis of temperature data is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033534: Vitalsense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033534
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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