Cleared Traditional

K162580 - Guardian Angel GA1000 Digital Vital Sign Monitoring System

K162580 is an FDA 510(k) clearance for Guardian Angel GA1000 Digital Vital Sig..., manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K162580 · Taiwan Aulisa Medical Devices Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
169d
Days
Class 2
Risk

K162580 is an FDA 510(k) clearance for the Guardian Angel GA1000 Digital Vital Sign Monitoring System. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on March 3, 2017 after a review of 169 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K162580

510(k) Number K162580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2016
Decision Date March 03, 2017
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 140d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K162580.
Nasal Alar SpO2 Sensor
K171423 · Xhale, Inc. · Jul 2017
Oxitone 1000
K163382 · Oxitone Medical , Ltd. · May 2017
Fingertip Pulse Oximeter
K161938 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · May 2017
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
K162014 · Bluepoint Medical GmbH & Co. KG · Feb 2017
Caremed Reusable & Disposable SPO2 Sensors
K153184 · Shenzhen Caremed Medical Technology Co., Ltd. · Jan 2017
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · Masimo Corporation · Dec 2016