Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Taiwan Aulisa Medical Devices Technologies, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
590 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-02-25 | 438 | 0 |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-01-30 | 412 | 0 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 | 245 | 0 |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitorin | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022-06-12 | 590 | 0 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020-10-30 | 60 | 0 |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring Syste | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-06-25 | 50 | 0 |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring Syst | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 | 148 | 0 |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring Syste | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 | 116 | 0 |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2017-03-03 | 169 | 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