Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Alicn Medical Shenzhen, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
289 daysmedian FDA review time
409 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, | Alicn Medical Shenzhen, Inc. | 2023-12-22 | 140 | 0 |
| K231050 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2023-10-11 | 181 | 0 |
| K230649 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2023-09-07 | 182 | 0 |
| K222248 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | 2023-06-07 | 316 | 0 |
| K221913 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2022-10-12 | 104 | 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 |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, | Alicn Medical Shenzhen, Inc. | 2022-05-04 | 289 | 0 |
| K212877 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2022-01-12 | 125 | 0 |
| K210564 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | 2022-01-07 | 316 | 0 |
| K210563 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2021-10-15 | 232 | 0 |
| K180435 | Arm Blood Pressure Monitor | Alicn Medical (Shenzhen), Inc. | 2019-01-03 | 317 | 0 |
| K180207 | Non-contact Infrared Thermometer | Alicn Medical (Shenzhen), Inc. | 2018-11-28 | 308 | 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