510(k) · Cleared
ClearedTyto Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyto Care, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Mar 27, 2019 as substantially equivalent to K134043 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2014) after a 49-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Mar 27, 2019
- Review
- 49 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011291 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
- 3 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
- 2 generations backK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
- 1 generation backK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
- This deviceK190242 Tyto ThermometerTyto Care, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK223785 N9+Nonagon, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223785N9+Nonagon, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011291 | Temporalscanner Thermometer, Sensortouch | Exergen Corp. | 2001 | — |
| −3 | K033790 | Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2004 | — |
| −2 | K081160 | Avita Radar Thermo IR Thermometer, NT1 Series | Avita Corporation | 2008 | — |
| −1 | K134043 | NO Touch+Forehead NTF 3000 Thermometer | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2014 | — |
| 0 (this device) | K190242 | Tyto Thermometer | Tyto Care, Ltd. | 2019 | — |
| +1 | K223785 | N9+ | Nonagon, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K134043 | NO Touch+Forehead NTF 3000 ThermometerSummary page 4…Panel: General Hospital Predicate Device(s): Device name 510(k) No. Date of Clearance No Touch + Forehead K134043 May 21, 2014 Thermometer NFT3000 The CliniCloud Thermometer (K161325) is used as the Reference Device. T… | 2014 |
| † | K161325 | CliniCloud Non-contact Thermometer, Model SPL1024 | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223785 | N9+ | 2023 | 0 |
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 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223785 (Nonagon, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K134043.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Tyto Thermometer is a non - contact clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190242: Tyto Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190242
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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