Cleared Traditional

K112126 - GENUINE FIRST AID CPR MASK

K112126 is an FDA 510(k) clearance for GENUINE FIRST AID CPR MASK, manufactured by Genuine First Aid, LLC. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K112126 · Genuine First Aid, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
129d
Days
Class 2
Risk

K112126 is an FDA 510(k) clearance for the GENUINE FIRST AID CPR MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Genuine First Aid, LLC (East Stroudsburg, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 129 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.

FDA 510(k) Submission Details - K112126

510(k) Number K112126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2011
Decision Date December 01, 2011
Days to Decision 129 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
11d faster than avg
Panel avg: 140d · This submission: 129d
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 Peers - CBP Valve, Non-rebreathing

All 86
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K112126.
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
EXHALATION VALVE
K132143 · Intersurgical Incorporated · Jun 2014
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
K111191 · Wet Nose Technologies, LLC · Jul 2011
CPR FACE MASK
K102299 · Genuine First Aid, LLC · Mar 2011
CPR MASK
K083418 · Firstar Healthcare Co., Ltd. · Jul 2010