Cleared Traditional

K192404 - Patient Monitoring Cable (SpO2 Extension Cable)

K192404 is an FDA 510(k) clearance for Patient Monitoring Cable (SpO2 Extensio..., manufactured by Shenzhen Coreray Technology, Ltd.. The device is a Class 2 Anesthesiology device with product code DSA cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K192404 · Shenzhen Coreray Technology, Ltd. · Anesthesiology device
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Jun 2020
Decision
293d
Days
Class 2
Risk

K192404 is an FDA 510(k) clearance for the Patient Monitoring Cable (SpO2 Extension Cable). Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Shenzhen Coreray Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 22, 2020 after a review of 293 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2900 - 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 Coreray Technology, Ltd. devices

FDA 510(k) Submission Details - K192404

510(k) Number K192404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date June 22, 2020
Days to Decision 293 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
153d slower than avg
Panel avg: 140d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 71
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