# Taiwan Aulisa Medical Devices Technologies, Inc.

- Location (FDA's records): Taipei, TW
- FDA decisions: 9 (2017–2025): 9 510(k) clearances
- Product codes: DQA (7), MSX (1), FLL (1)
- 510(k) review time since 2016: median 169 days, against 182 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 11 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nonin Medical, Inc.: 3 (https://510kreport.com/company/nonin-medical)
- VivaLNK, Inc.: 2 (https://510kreport.com/company/vivalnk)
- Earlysense, Ltd.: 1 (https://510kreport.com/company/earlysense)
- Sotera Wireless, Inc.: 1 (https://510kreport.com/company/sotera-wireless)

## Firms that cite its devices most
- Owlet Babycare, Inc.: 1 (https://510kreport.com/company/owlet-babycare)
- Sibel Health, Inc.: 1 (https://510kreport.com/company/sibel-health)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- True Wearables, Inc.: 1 (https://510kreport.com/company/true-wearables)

## Its most-cited devices
- K182822: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (2019), cited by 3
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (2022), cited by 3
- K162580: Guardian Angel GA1000 Digital Vital Sign Monitoring System (2017), cited by 2
- K202497: Aulisa Multiple Patient Digital Vital Sign Monitoring System (2020), cited by 1
- K191207: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (2019), cited by 1
- K183067: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (2019), cited by 1

## Recent decisions
- K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (Feb 25, 2025)
- K233956: Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (Jan 30, 2025)
- K240220: Aulisa Temperature Module (TM0002) (Sep 27, 2024)
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Jun 12, 2022)
- K202497: Aulisa Multiple Patient Digital Vital Sign Monitoring System (Oct 30, 2020)
- K191207: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (Jun 25, 2019)
- K182822: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (Mar 1, 2019)
- K183067: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (Mar 1, 2019)

Source page: https://510kreport.com/company/taiwan-aulisa-medical-devices-technologies