Class Class II
Infrared Thermometer TET-351 (K220276)
Description
Infrared Thermometer TET-351 by Truly Instrument Limited, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220276
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeFLL
Regulation Number880.2910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220276
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Infrared Thermometer TET-351 (K220276) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190873 | Infrared Ear/Forehead Thermometer | Joytech Healthcare Co. , Ltd. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co.... | 2023 |
Trace the full predicate network for K220276
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.