Taiwan Aulisa Medical Devices Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Taiwan Aulisa Medical Devices Technologies, Inc.” (first 2017, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 169 days. Since 2017 the median was 169 days, against 208 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 |
|---|---|---|
| 2017 | 1 | 169 |
| 2018 | 0 | — |
| 2019 | 3 | 116 |
| 2020 | 1 | 60 |
| 2021 | 0 | — |
| 2022 | 1 | 590 |
| 2023 | 0 | — |
| 2024 | 1 | 245 |
| 2025 | 2 | 425 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Taiwan Aulisa Medical Devices Technologies, Inc. took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 208 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 7 | 7 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Anesthesiology (7)
- Cardiovascular (1)
- General Hospital (1)
Most recent Taiwan Aulisa Medical Devices Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | DQA | 2025-02-25 | 438 |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | DQA | 2025-01-30 | 412 |
| K240220 | Aulisa Temperature Module (TM0002) | FLL | 2024-09-27 | 245 |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | DQA | 2022-06-12 | 590 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | MSX | 2020-10-30 | 60 |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System | DQA | 2019-06-25 | 50 |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | DQA | 2019-03-01 | 116 |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System | DQA | 2019-03-01 | 148 |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System | DQA | 2017-03-03 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Taiwan Aulisa Medical Devices Technologies, 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.
Device clinical trials
An industry sponsor named Taiwan Aulisa Medical Devices Technologies, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03870373: Performance of Pulse Oximeter Sensors in Neonates (Completed, started 2019-02-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Taiwan Surgical Corporation (9 510(k)s)
- Taiwan Armada Enterprise Co., Ltd. (5 510(k)s)
- Taiwan King Strong Co., Ltd. (4 510(k)s)
- Taiwan Eva Industrial Co., Inc. (3 510(k)s)
- Taiwan Main Orthopaedic Biotechnology Co., Ltd. (3 510(k)s)
- Taiwan an I Co., Ltd. (2 510(k)s)
- Taiwan Biomaterial Co., Ltd. (2 510(k)s)
- Taiwan Link Sdn Bhd (2 510(k)s)
- Taiwan Scientific Corporation (2 510(k)s)
- Taiwan an Lih Ent. Co. , Ltd. (1 510(k)s)
- Taiwan Biophotonic Corporation (1 510(k)s)
- Taiwan Comfort Champ Manufacturing Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Taiwan Aulisa Medical Devices Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Taiwan Aulisa Medical Devices Technologies, Inc.” (first 2017, latest 2025), across 3 product codes in 3 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 Taiwan Aulisa Medical Devices Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Taiwan Aulisa Medical Devices Technologies, Inc. is 169 days. Since 2017: 169 days, versus 208 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Taiwan Aulisa Medical Devices Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 7); FLL (Continuous Measurement Thermometer, 1); MSX (System, Network And Communication, Physiological Monitors, 1).
Next steps
- See all 9 Taiwan Aulisa Medical Devices Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Taiwan Aulisa Medical Devices Technologies, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.