Cleared Traditional

K223399 - AViTA Pulse Oximeter

K223399 is the FDA 510(k) clearance for AViTA Pulse Oximeter by Avita Corporation. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 558-day FDA review.

K223399 · Avita Corporation · Anesthesiology device
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May 2024
Decision
558d
Days
Class 2
Risk

K223399 is an FDA 510(k) clearance for the AViTA Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on May 20, 2024 after a review of 558 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 Avita Corporation devices

Submission Details

510(k) Number K223399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2022
Decision Date May 20, 2024
Days to Decision 558 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
418d slower than avg
Panel avg: 140d · This submission: 558d
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 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K223399.
Pulse Oximeter (AOJ-70A)
K232989 · Shenzhen AOJ Medical Technology Co., Ltd. · Jul 2024
Pulse Oximeter (MD300C228)
K232975 · Beijing Choice Electronic Technology Co., Ltd. · Jun 2024
ANNE Limb
K240305 · Sibel Health, Inc. · May 2024
Sempulse Halo Vital Signs Monitor
K232495 · Sempulse Corporation · May 2024
Vyvo
K231288 · Vyvo Technology Corp.(Vt) · Mar 2024
Pulse Oximeter(Model OHT60,OXH78)
K230277 · Cofoe Medical Technology Co., Ltd. · Jan 2024