Cleared Traditional

Oxyfit Pulse Oximeter (K203812) - FDA 510(k) Clearance

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

K203812 · Shenzhen Viatom Technology Co., Ltd. · Anesthesiology device
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Nov 2022
Decision
680d
Days
Class 2
Risk

K203812 is an FDA 510(k) clearance for the Oxyfit Pulse Oximeter. 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 November 8, 2022 after a review of 680 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 Shenzhen Viatom Technology Co., Ltd. devices

Submission Details

510(k) Number K203812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date November 08, 2022
Days to Decision 680 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
540d slower than avg
Panel avg: 140d · This submission: 680d
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 K203812.
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