Cleared Traditional

K052743 - DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921

K052743 is an FDA 510(k) clearance for DYNAREX CPR SHIELD WITH ONE WAY VALVE A..., manufactured by Dynarex Corp.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K052743 · Dynarex Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
83d
Days
Class 2
Risk

K052743 is an FDA 510(k) clearance for the DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Dynarex Corp. (Orangeburg, US). The FDA issued a Cleared decision on December 22, 2005 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dynarex Corp. devices

FDA 510(k) Submission Details - K052743

510(k) Number K052743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
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 80
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K052743.
OXYGEN DEMAND VALVE
K082345 · Bpr Medical, Ltd. · Mar 2009
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
K081516 · Medsource International, LLC · Aug 2008
LIV MEDICA CPR FACE MASK
K052458 · Liv Medica Products Pvt. , Ltd. · Jul 2006
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
K042727 · Foremount Ent. Co., Ltd. · Mar 2005
MERLIN E-MASK
K031397 · Merlin Medical Limited · Jul 2004
BAWMED RESCUE MASK
K031431 · Bawmed UK · Jul 2004