Cleared Traditional

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (K183067) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183067 · Taiwan Aulisa Medical Devices Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
116d
Days
Class 2
Risk

K183067 is an FDA 510(k) clearance for the Guardian Angel Rx GA2000 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 1, 2019 after a review of 116 days - within the typical 510(k) review window.

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.

View all Taiwan Aulisa Medical Devices Technologies, Inc. devices

Submission Details

510(k) Number K183067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2018
Decision Date March 01, 2019
Days to Decision 116 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
24d faster than avg
Panel avg: 140d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Don Mizota
Don Mizota

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K183067.
Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
K181738 · Surgical Instrument Service and Savings Inc (Dba Medline · Mar 2019
Masimo Rad-67 Pulse CO-Oximeter and Accessories
K182887 · Masimo Corporation · Mar 2019
Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
K182822 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2019
oCare Wrist Pulse Oximeter
K183556 · Taiwan Biophotonic Corporation · Feb 2019
Masimo MightySat Rx Fingertip Pulse Oximeter
K181956 · Masimo Corporation · Jan 2019
vital signs monitor
K180380 · Edan Instruments, Inc. · Dec 2018