Cleared Traditional

Pulse Oximeter ( PO2, PO2A, PO2B) (K242876) - FDA 510(k) Clearance

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

K242876 · Shenzhen Viatom Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
158d
Days
Class 2
Risk

K242876 is an FDA 510(k) clearance for the Pulse Oximeter ( PO2, PO2A, PO2B). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Viatom Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 28, 2025 after a review of 158 days - an extended review cycle.

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 Shenzhen Viatom Technology Co., Ltd. devices

Submission Details

510(k) Number K242876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2024
Decision Date February 28, 2025
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
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

Irc
Charles Mack

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 K242876.
Pulse Oximeter
K250837 · Shanghai Berry Electronic Tech Co., Ltd. · Sep 2025
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
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
K233963 · Taiwan Aulisa Medical Devices Technologies, Inc. · 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