Cleared Traditional

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (K233956) - FDA 510(k) Clearance

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

K233956 · Taiwan Aulisa Medical Devices Technologies, Inc. · Anesthesiology device
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Jan 2025
Decision
412d
Days
Class 2
Risk

K233956 is an FDA 510(k) clearance for the Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018). 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 January 30, 2025 after a review of 412 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 K233956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date January 30, 2025
Days to Decision 412 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
272d slower than avg
Panel avg: 140d · This submission: 412d
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 K233956.
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
Pulse Oximeter (FS20P)
K243049 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Jan 2025
Evie Med Ring
K241090 · Movano Inc. Dba Movano Health · Nov 2024
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
K232520 · Shenzhen Smallsignal Technology Co., Ltd. · Nov 2024