Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FLL — Predicate Candidate Screening
798 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
294 days90th percentile
798clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); | Unimed Medical Supplies, Inc. | 2026-06-05 | 252 | 0 |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS- | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 | 268 | 0 |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 | 125 | 0 |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Dis | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 | 267 | 0 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 | 59 | 0 |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 | 207 | 0 |
| K250401 | AION TempShield™ | Aion Biosystems, Inc. | 2025-03-14 | 30 | 0 |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR2 | Shenzhen Finicare Co., Ltd. | 2025-02-14 | 137 | 0 |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 | 268 | 0 |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 | 273 | 0 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 | 245 | 0 |
| K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, | Covidien | 2024-08-20 | 223 | 0 |
| K233280 | SteadyTemp | Steadysense GmbH | 2024-06-21 | 266 | 0 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 | 90 | 0 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 | 87 | 0 |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 | 190 | 0 |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd | 2024-04-03 | 369 | 0 |
| K240023 | Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. | 2024-03-01 | 58 | 0 |
| K232473 | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2024-02-09 | 177 | 0 |
| K231625 | VitalDetect | Wellvii, Inc. | 2024-02-02 | 245 | 0 |
| K232678 | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | 2024-01-31 | 152 | 0 |
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, | Alicn Medical Shenzhen, Inc. | 2023-12-22 | 140 | 0 |
| K222057 | THERMOCLICK | T&R BIOFAB CO., Ltd. | 2023-12-05 | 511 | 0 |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20 | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-10-14 | 89 | 0 |
| K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-25 | 248 | 0 |
| K230298 | Celsi Monitor | Hadleigh Health Technologies | 2023-08-16 | 195 | 0 |
| K232010 | iTEMPSHIELD | Aion Biosystems, Inc. | 2023-08-04 | 29 | 0 |
| K223037 | Infrared Thermometer, Model: IR8807 | Shen Zhen Rong Feng Technology Co., Ltd. | 2023-07-21 | 295 | 0 |
| K213100 | FMT Reusable Temperature Probes | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti | 2023-07-18 | 662 | 0 |
| K210924 | e-Celsius Medical System | Bodycap | 2023-06-28 | 821 | 0 |
| K223522 | NC° Thermometer (Gen 3), Model Number: NCTG3 | Xiamen Intretech, Inc. | 2023-06-20 | 209 | 0 |
| K222248 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | 2023-06-07 | 316 | 0 |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperatur | Circa Scientific, Inc. | 2023-05-25 | 297 | 0 |
| K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | 2023-05-10 | 223 | 0 |
| K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | Iweecare Co., Ltd. | 2023-02-17 | 175 | 0 |
| K220276 | Infrared Thermometer TET-351 | Truly Instrument Limited | 2023-02-17 | 382 | 0 |
| K220657 | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60 | Zhejiang Rongsheng Industrial Co., Ltd. | 2023-02-10 | 340 | 0 |
| K214077 | Digital Thermometer, Model: DT007, DT008 | Guangzhou Berrcom Medical Device Co., Ltd. | 2023-01-20 | 389 | 0 |
| K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ- | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-12-20 | 257 | 0 |
| K221800 | Infrared Thermometer (Model: Y20001, Y20002) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022-12-14 | 176 | 0 |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH- | Jkh Health Co., Ltd. | 2022-11-28 | 599 | 0 |
| K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, A | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-10-07 | 168 | 0 |
| K221211 | Infrared thermometer | Shenzhen Yolanda Technology Co., Ltd. | 2022-09-27 | 153 | 0 |
| K220084 | Infrared Forehead Thermometer | Qingdao Yasee Medical Device Co., Ltd. | 2022-09-12 | 245 | 0 |
| K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ- | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-05-25 | 208 | 0 |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, | Alicn Medical Shenzhen, Inc. | 2022-05-12 | 409 | 0 |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, A | Alicn Medical Shenzhen, Inc. | 2022-05-05 | 434 | 0 |
| K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1 | Shenzhen Pango Medical Electronics Co., Ltd. | 2022-05-05 | 281 | 0 |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, | Alicn Medical Shenzhen, Inc. | 2022-05-04 | 289 | 0 |
| K213011 | Infrared Thermometer (model: E201) | Bioland Technology, Ltd. | 2022-04-05 | 197 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda