Cleared Traditional

Pulse Oximeter (K191430) - FDA 510(k) Clearance

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

K191430 · Shenzhen Yimi Life-Technology Co., Ltd. · Anesthesiology device
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Oct 2019
Decision
142d
Days
Class 2
Risk

K191430 is an FDA 510(k) clearance for the Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Yimi Life-Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 18, 2019 after a review of 142 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 Yimi Life-Technology Co., Ltd. devices

Submission Details

510(k) Number K191430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2019
Decision Date October 18, 2019
Days to Decision 142 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
2d slower than avg
Panel avg: 140d · This submission: 142d
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 Peers - DQA Oximeter

All 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K191430.
Pulse Oximeter
K191403 · Nonin Medical, Inc. · Dec 2019
Disposable SpO2 Sensor
K191279 · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 2019
Checkme O2 Pulse Oximeter
K191088 · Shenzhen Viatom Technology Co., Ltd. · Dec 2019
Reusable SpO2 Sensor
K191420 · Shenzhen Changke Connect Electronics Co., Ltd. · Oct 2019
Belun Ring
K191417 · Belun Technology Company Limited · Oct 2019
Pulse Oximeter
K190869 · Shenzhen Aeon Technology Co., Ltd. · Sep 2019