Cleared Traditional

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (K233963) - FDA 510(k) Clearance

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

K233963 · Taiwan Aulisa Medical Devices Technologies, Inc. · Anesthesiology device
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Feb 2025
Decision
438d
Days
Class 2
Risk

K233963 is an FDA 510(k) clearance for the Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei City, TW). The FDA issued a Cleared decision on February 25, 2025 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Taiwan Aulisa Medical Devices Technologies, Inc. devices

Submission Details

510(k) Number K233963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date February 25, 2025
Days to Decision 438 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
298d slower than avg
Panel avg: 140d · This submission: 438d
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 Peers - DQA Oximeter

All 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K233963.
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)
K250931 · Unimed Medical Supplies, Inc. · Aug 2025
Avidhrt Sense SpO2
K241086 · Avidhrt, Inc. · May 2025
Pulse Oximeter ( PO2, PO2A, PO2B)
K242876 · Shenzhen Viatom Technology Co., Ltd. · Feb 2025
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91)
K243086 · Unimed Medical Supplies, Inc. · Feb 2025
AViTA Pulse Oximeter (SP62B)
K242455 · Avita Corporation · Feb 2025
Unimed Reusable Finger Clip SpO2 Sensors (U103-125)
K242580 · Unimed Medical Supplies, Inc. · Feb 2025