Cleared Traditional

K191279 - Disposable SpO2 Sensor

K191279 is the FDA 510(k) clearance for Disposable SpO2 Sensor by Shenzhen Caremed Medical Technology Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K191279 · Shenzhen Caremed Medical Technology Co., Ltd. · Anesthesiology device
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Dec 2019
Decision
207d
Days
Class 2
Risk

K191279 is an FDA 510(k) clearance for the Disposable SpO2 Sensor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Caremed Medical Technology Co., Ltd. (Dalang Office, Longhua District, Shenzhe, CN). The FDA issued a Cleared decision on December 6, 2019 after a review of 207 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 Caremed Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K191279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date December 06, 2019
Days to Decision 207 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
67d slower than avg
Panel avg: 140d · This submission: 207d
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 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K191279.
Disposable SpO2 Sensor
K192608 · Shenzhen Sino-K Medical Technology Co.,Ltd · Jan 2020
Patient Monitor
K192343 · Shenzhen Creative Industry Co., Ltd. · Dec 2019
Pulse Oximeter
K191403 · Nonin Medical, Inc. · Dec 2019
Checkme O2 Pulse Oximeter
K191088 · Shenzhen Viatom Technology Co., Ltd. · Dec 2019
Pulse Oximeter
K191430 · Shenzhen Yimi Life-Technology Co., Ltd. · Oct 2019
Reusable SpO2 Sensor
K191420 · Shenzhen Changke Connect Electronics Co., Ltd. · Oct 2019