Cleared Traditional

Fingertip pulse oximeter (K202776) - FDA 510(k) Clearance

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

K202776 · Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. · Anesthesiology device
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Mar 2021
Decision
161d
Days
Class 2
Risk

K202776 is an FDA 510(k) clearance for the Fingertip pulse oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 1, 2021 after a review of 161 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 Lepu Intelligent Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K202776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2020
Decision Date March 01, 2021
Days to Decision 161 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
21d slower than avg
Panel avg: 140d · This submission: 161d
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

FDA Regulatory and Quality Systems Consultant
Arthur Goddard

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 183
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K202776.
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K202324 · Shenzhen Bsx Technology Electronics Co., Ltd. · Dec 2020
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K201384 · Shenzhen Raysintone Technology Co., Ltd. · Dec 2020