Cleared Traditional

Pulse Oximeter (K210305) - FDA 510(k) Clearance

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

K210305 · Dongguan Lingxin Technologies Co., Ltd. · Anesthesiology device
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Dec 2021
Decision
322d
Days
Class 2
Risk

K210305 is an FDA 510(k) clearance for the Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dongguan Lingxin Technologies Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 22, 2021 after a review of 322 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 Dongguan Lingxin Technologies Co., Ltd. devices

Submission Details

510(k) Number K210305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2021
Decision Date December 22, 2021
Days to Decision 322 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
182d slower than avg
Panel avg: 140d · This submission: 322d
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

Shenzhen Reanny Medical Devices Mangement Consulting., Ltd.
Reanny Wang

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 K210305.
Pulse Oximeter
K212300 · Shenzhen Mericonn Technology Co., Ltd. · Feb 2022
Pulse Oximeter
K211400 · Beijing Choice Electronic Technology Co., Ltd. · Feb 2022
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
K211632 · Shenzhen Narig Bio-Medical Technology Co., Ltd. · Jan 2022
Belun Ring BLR-100X
K211407 · Belun Technology Company Limited · Oct 2021
Carescape SpO2 - Masimo
K212876 · Masimo Corporation · Oct 2021
Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
K210032 · Leadtek Research, Inc. · Sep 2021