FDA applicant

Taiwan Aulisa Medical Devices Technologies, Inc.

Taipei, TW9 decisions2017–20250 recalls

FDA records 9 decisions for Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei, TW) from 2017 to 2025: 9 510(k) clearances. Most are in product codes DQA (Oximeter) and MSX (System, Network And Communication…). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Taiwan Aulisa Medical Devices Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2017high 3 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Taiwan Aulisa Medical Devices Technologies, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Taiwan Aulisa Medical Devices…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

DQAOximeter7decisions
MSXSystem, Network And Communication, Physiological Monitors1decision
FLLContinuous Measurement Thermometer1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 169 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 5 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 20193cite it
K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 20223cite it
K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 20172cite it
K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 20201cites it
K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 20191cites it
K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 20191cites it

What has FDA decided for it lately?

K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025
K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025
K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc. · 2024
K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022
K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2020
K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019

All 9 as Taiwan Aulisa Medical Devices Technologies, Inc. →