Cleared Traditional

Reusable SpO2 Sensor (K191420) - FDA 510(k) Clearance

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

K191420 · Shenzhen Changke Connect Electronics Co., Ltd. · Anesthesiology device
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Oct 2019
Decision
136d
Days
Class 2
Risk

K191420 is an FDA 510(k) clearance for the Reusable SpO2 Sensor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Changke Connect Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 11, 2019 after a review of 136 days - within the typical 510(k) review window.

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 Changke Connect Electronics Co., Ltd. devices

Submission Details

510(k) Number K191420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2019
Decision Date October 11, 2019
Days to Decision 136 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
4d faster than avg
Panel avg: 140d · This submission: 136d
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

Chonconn Medical Device Consulting Co., Ltd.
Kevin 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 183
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K191420.
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Pulse Oximeter
K191430 · Shenzhen Yimi Life-Technology Co., Ltd. · Oct 2019
Belun Ring
K191417 · Belun Technology Company Limited · Oct 2019
Pulse Oximeter
K190869 · Shenzhen Aeon Technology Co., Ltd. · Sep 2019
BB-613WP
K190792 · Biobeat Technologies , Ltd. · Aug 2019