Cleared Traditional

K212665 - Pulse Oximeter (Model Number-SO611)

K212665 is an FDA 510(k) clearance for Pulse Oximeter (Model Number-SO611), manufactured by Huizhou Xiaoou Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 303-day FDA review.

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

FDA 510(k) Submission Details - K212665

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.

DQA Device Classification - Class 2, Special Controls

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 464
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K212665.
Pulse Oximeter (Model C101A2, C101B1, C101A3)
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Med-link Pulse Oximeter
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