Cleared Traditional

K142764 - KYOLING CPR Mask with Oxygen Port and Without Oxygen Port

K142764 is an FDA 510(k) clearance for KYOLING CPR Mask with Oxygen Port and W..., manufactured by Hangzhou Jinlin Medical Appliances Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K142764 · Hangzhou Jinlin Medical Appliances Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
287d
Days
Class 2
Risk

K142764 is an FDA 510(k) clearance for the KYOLING CPR Mask with Oxygen Port and Without Oxygen Port. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Hangzhou Jinlin Medical Appliances Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 9, 2015 after a review of 287 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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.

FDA 510(k) Submission Details - K142764

510(k) Number K142764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date July 09, 2015
Days to Decision 287 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
147d slower than avg
Panel avg: 140d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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

Osmunda Medical Device Consulting Co., Ltd.
Mike Gu

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 - CBP Valve, Non-rebreathing

All 86
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K142764.
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