Cleared Traditional

DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921

K052743 · Dynarex Corp. · Anesthesiology
Dec 2005
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K052743 is an FDA 510(k) clearance for the DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Dynarex Corp. (Orangeburg, US). The FDA issued a Cleared decision on December 22, 2005, 83 days after receiving the submission on September 30, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K052743 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2005
Decision Date December 22, 2005
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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

Similar Devices — CBP Valve, Non-rebreathing

All 102
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
K241366 · Dehas Medical Systems GmbH · Oct 2024
F&P Optiflow Flow Diverter
K234053 · Fisher &Paykel Healthcare , Ltd. · Aug 2024
Altech? Exhalation Valve (Single Limb and Dual Limb)
K210992 · Meditera Tibbi Malzeme San VE Tic AS · Dec 2021
CPR Face Shield
K192285 · Firstar Healthcare Company Limited (Guangzhou) · Nov 2020
OJR215 Pressure Relief Manifold
K173770 · Fisher & Paykel Healthcare Limited · Apr 2019
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 · Xiamen Compower Medical Tech. Co., Ltd. · Nov 2017