Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
FDA 510(k) K221039 · Shenzhen AOJ Medical Technology Co., Ltd.
510(k) numberK221039
Submission
- Device name
- Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd.
Shenzhen, CN - Received
- April 7, 2022
- Decision date
- December 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLL – Continuous Measurement Thermometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2910
- Specialty
- General Hospital
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Other 510(k)s with product code FLL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional | Unimed Medical Supplies, Inc. | 06/05/2026SE |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 01/08/2026SE |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 06/23/2025SE |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…FLL · Traditional | Shenzhen Medke Technology Co., Ltd. | 06/20/2025SE |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 05/22/2025SE |
| K243082 | Infrared ThermometerFLL · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 04/25/2025SE |
| K250401 | AION TempShieldFLL · Traditional | Aion Biosystems, Inc. | 03/14/2025SE |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…FLL · Traditional | Shenzhen Finicare Co., Ltd. | 02/14/2025SE |
| K240333 | Wearable Digital Thermometer (T31)FLL · Traditional | Guangdong Genial Technology Co., Ltd. | 10/30/2024SE |
| K240223 | FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional | Metko Medikal VE Tibbi Cihazlar Dis Ticaret… | 10/25/2024SE |
More from Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
| 510(k) | Device | Decision |
|---|---|---|
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro…DXN · Special | 04/01/2026SE |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional | 06/23/2025SE |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…DXN · Traditional | 05/02/2025SE |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood…DXN · Traditional | 04/30/2025SE |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood…DXN · Traditional | 04/24/2025SE |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse…DQA · Traditional | 07/01/2024SE |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)FLL · Traditional | 10/14/2023SE |
| K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BDXN · Traditional | 07/26/2023SE |
| K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F…DXN · Traditional | 12/01/2022SE |
| K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106…FLL · Traditional | 10/07/2022SE |
Questions and answers
When was Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y cleared by the FDA?
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y (K221039) received a 510(k) decision of Substantially Equivalent on December 20, 2022, 257 days after the submission was received.
What is the product code of K221039?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.