Cleared Traditional

K171961 - Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

K171961 is an FDA 510(k) clearance for Compower CPR Mask With Oxygen Port, manufactured by Xiamen Compower Medical Tech. Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K171961 · Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology device
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Nov 2017
Decision
140d
Days
Class 2
Risk

K171961 is an FDA 510(k) clearance for the Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Co.... Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Xiamen Compower Medical Tech. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on November 17, 2017 after a review of 140 days - within the typical 510(k) review window.

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.

View all Xiamen Compower Medical Tech. Co., Ltd. devices

FDA 510(k) Submission Details - K171961

510(k) Number K171961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date November 17, 2017
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
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

Namsa
Lynn Jensen

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 70
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K171961.
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K152521 · The Lifeguard Store, Inc. · Jun 2016
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
K142764 · Hangzhou Jinlin Medical Appliances Co., Ltd. · Jul 2015
BigEasy Non-Rebreathing Valve
K142402 · 12th Man Technologies, Inc. · Mar 2015