510(k) · Cleared
ClearedVDT985US Vicks SmartTemp Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaz USA, Inc., A Helen of Troy Company · FLL Continuous Measurement Thermometer
Cleared on Mar 23, 2016 as substantially equivalent to K043110 (Microlife Intellectual Property GmbH, 2004) and 1 other predicate after a 167-day review. Its family tree reaches back 8 generations to 2001. 3 later devices descend from it.
- Decided
- Mar 23, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K010462 (2001). 15 ancestors in all, the oldest K943695 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 7 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 6 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 5 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 4 generations backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- 3 generations backK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- 2 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 1 generation backK132761 Wireless ThermometerRaiing Medical Company · 2014
- This deviceK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- Descendant · cites it directly · 2 of its ownK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- Descendant · 2 generations on · 1 of its ownK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK211352 Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018 · cites it directly2descendants
- K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021 · 2 generations on1descendant
- K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −7 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −6 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −5 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −4 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| −3 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| −2 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| −1 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| 0 (this device) | K152975 | VDT985US Vicks SmartTemp Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2016 | — |
| +1 | K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2018 | — |
| +2 | K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | 2021 | — |
| +3 | K211352 | Electronic Thermometer (XHF2001, XHF2002) | Putian Hanjiang Huafeng Plastic Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K043110 | Microlife Instant Digital Electronic Thermometer, Model MT18L1Summary page 4…Number MT18I1 (V966) Instant Digital Electronic Microlife Corporation K043110 Thermometer WT701 Wireless Thermometer Raiing Medical K132761… | 2004 |
| * | K132761 | Wireless ThermometerSummary page 4…tronic Microlife Corporation K043110 Thermometer WT701 Wireless Thermometer Raiing Medical K132761 Company 5. Device Description: Overview: T… | 2014 |
| † | K030580 | Suretemp Plus | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180131 | Vicks RapidRead Digital Thermometer | 2018 | 2 |
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 15 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K180131 (Kaz USA, Inc., A Helen of Troy Company, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K043110.
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 VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152975: VDT985US Vicks SmartTemp Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152975
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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