Cleared Traditional

AViTA Pulse Oximeter (SP61)

K252448 · Avita Corporation · Anesthesiology
Feb 2026
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K252448 is an FDA 510(k) clearance for the AViTA Pulse Oximeter (SP61), a Oximeter (Class II — Special Controls, product code DQA), submitted by Avita Corporation (New Taipei City, CN). The FDA issued a Cleared decision on February 27, 2026, 207 days after receiving the submission on August 4, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K252448 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2025
Decision Date February 27, 2026
Days to Decision 207 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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