Cleared Traditional

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) (K212665) - FDA 510(k) Clearance

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

K212665 · Huizhou Xiaoou Technology Co., Ltd. · Anesthesiology device
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Jun 2022
Decision
303d
Days
Class 2
Risk

K212665 is an FDA 510(k) clearance for the Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pu.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Huizhou Xiaoou Technology Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on June 22, 2022 after a review of 303 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Huizhou Xiaoou Technology Co., Ltd. devices

Submission Details

510(k) Number K212665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2021
Decision Date June 22, 2022
Days to Decision 303 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
163d slower than avg
Panel avg: 140d · This submission: 303d
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 188
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K212665.
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Med-link Pulse Oximeter
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