Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shenzhen AOJ Medical Technology Co., Ltd. · Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

125 daysmedian FDA review time
283 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260276Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HShenzhen AOJ Medical Technology Co., Ltd.2026-04-01620
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Shenzhen AOJ Medical Technology Co., Ltd.2025-06-231250
K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood PressureShenzhen AOJ Medical Technology Co., Ltd.2025-05-021010
K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure MonShenzhen AOJ Medical Technology Co., Ltd.2025-04-301250
K250116Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure MonShenzhen AOJ Medical Technology Co., Ltd.2025-04-24980
K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse OxShenzhen AOJ Medical Technology Co., Ltd.2024-07-012830
K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Shenzhen AOJ Medical Technology Co., Ltd.2023-10-14890
K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BShenzhen AOJ Medical Technology Co., Ltd.2023-07-263010
K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-Shenzhen AOJ Medical Technology Co., Ltd.2022-12-202570
K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30CShenzhen AOJ Medical Technology Co., Ltd.2022-12-011360
K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AShenzhen AOJ Medical Technology Co., Ltd.2022-10-071680
K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-Shenzhen AOJ Medical Technology Co., Ltd.2022-05-252080
K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-3Shenzhen AOJ Medical Technology Co., Ltd.2022-02-181090
K202173Pulse OximeterShenzhen AOJ Medical Technology Co., Ltd.2020-12-071260
K191180Electronic Blood Pressure MonitorShenzhen AOJ Medical Technology Co., Ltd.2019-08-231130
K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd.2018-12-191280
K182133Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd.2018-11-201060

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