Cleared Traditional

Disposable SpO2 Sensor (K192608) - FDA 510(k) Clearance

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

K192608 · Shenzhen Sino-K Medical Technology Co.,Ltd · Anesthesiology device
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Jan 2020
Decision
126d
Days
Class 2
Risk

K192608 is an FDA 510(k) clearance for the Disposable SpO2 Sensor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Sino-K Medical Technology Co.,Ltd (Baoan District, Shenzhen, CN). The FDA issued a Cleared decision on January 24, 2020 after a review of 126 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 Sino-K Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K192608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2019
Decision Date January 24, 2020
Days to Decision 126 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
14d faster than avg
Panel avg: 140d · This submission: 126d
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 K192608.
Leadtek Fingertip Pulse Oximeter
K193350 · Leadtek Research, Inc. · Apr 2020
OxSAT 100
K191574 · S.L.P. , Ltd. · Apr 2020
Disposable SpO2 Sensor
K200069 · Shenzhen Changke Connect Electronics Co., Ltd. · Mar 2020
Patient Monitor
K192343 · Shenzhen Creative Industry Co., Ltd. · Dec 2019
Pulse Oximeter
K191403 · Nonin Medical, Inc. · Dec 2019
Disposable SpO2 Sensor
K191279 · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 2019