510(k) · Cleared
ClearedInfrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Changkun Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jun 17, 2020 as substantially equivalent to K170662 (Intrinity Global Limited, 2017) after a 212-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it.
- Decided
- Jun 17, 2020
- Review
- 212 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011291 (2001). 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
- 4 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
- 3 generations backK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
- 2 generations backK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
- 1 generation backK170662 Non Contact Infrared Forehead ThermometerIntrinity Global Limited · 2017
- This deviceK193253 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK243136 Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205…Shenzhen Finicare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK221170 Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK220084 Infrared Forehead ThermometerQingdao Yasee Medical Device Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK203454 Infrared ThermometerShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…Shenzhen Finicare Co., Ltd. · 2025 · cites it directly0descendants
- K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106…Shenzhen AOJ Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
- K220084Infrared Forehead ThermometerQingdao Yasee Medical Device Co., Ltd. · 2022 · cites it directly0descendants
- K203454Infrared ThermometerShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011291 | Temporalscanner Thermometer, Sensortouch | Exergen Corp. | 2001 | — |
| −4 | K033790 | Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2004 | — |
| −3 | K081160 | Avita Radar Thermo IR Thermometer, NT1 Series | Avita Corporation | 2008 | — |
| −2 | K134043 | NO Touch+Forehead NTF 3000 Thermometer | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2014 | — |
| −1 | K170662 | Non Contact Infrared Forehead Thermometer | Intrinity Global Limited | 2017 | — |
| 0 (this device) | K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | Shenzhen Changkun Technology Co., Ltd. | 2020 | — |
| +1 | K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202… | Shenzhen Finicare Co., Ltd. | 2025 | — |
| +1 | K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105… | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +1 | K220084 | Infrared Forehead Thermometer | Qingdao Yasee Medical Device Co., Ltd. | 2022 | — |
| +1 | K203454 | Infrared Thermometer | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K170662 | Non Contact Infrared Forehead ThermometerSummary page 5…ed Forehead Thermometer(model : TVT-200, TVT-200 PLUS) Common Name: Clinical electronic thermometer Classification Name: Thermometer, Electronic, Clinical 510(K) Number: K170662 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: II 5. Device Description Infrare… | 2017 |
What descends from it? (4)
4 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 19 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K243136 (Shenzhen Finicare Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K170662.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Infrared Thermometer (model: CK-T1501, CK-T1502, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193253: Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193253
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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