Alicn Medical Shenzhen, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Alicn Medical Shenzhen, Inc.” (first 2018, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 289 days. Since 2017 the median was 289 days, against 182 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 308 |
| 2019 | 1 | 317 |
| 2020 | 0 | — |
| 2021 | 1 | 232 |
| 2022 | 6 | 302 |
| 2023 | 4 | 182 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alicn Medical Shenzhen, Inc. took a median 289 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 7 | 7 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 6 | 6 |
Review panels
- General Hospital (7)
- Cardiovascular (6)
Most recent Alicn Medical Shenzhen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | FLL | 2023-12-22 | 140 |
| K231050 | Arm Blood Pressure Monitor | DXN | 2023-10-11 | 181 |
| K230649 | Arm Blood Pressure Monitor | DXN | 2023-09-07 | 182 |
| K222248 | Infrared Thermometer | FLL | 2023-06-07 | 316 |
| K221913 | Arm Blood Pressure Monitor | DXN | 2022-10-12 | 104 |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | FLL | 2022-05-12 | 409 |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | FLL | 2022-05-05 | 434 |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | FLL | 2022-05-04 | 289 |
| K212877 | Arm Blood Pressure Monitor | DXN | 2022-01-12 | 125 |
| K210564 | Infrared Thermometer | FLL | 2022-01-07 | 316 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alicn Medical Shenzhen, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Alicn Medical Shenzhen, Inc. (11)
- Alicn Medical (Shenzhen), Inc. (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alicn Medical Shenzhen, Inc.?
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Alicn Medical Shenzhen, Inc.” (first 2018, latest 2023), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alicn Medical Shenzhen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alicn Medical Shenzhen, Inc. is 289 days. Since 2017: 289 days, versus 182 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alicn Medical Shenzhen, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 7); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 6).
Next steps
- See all 13 Alicn Medical Shenzhen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Alicn Medical Shenzhen, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.