# K052743: Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corp.
- Decided: Dec 22, 2005 after 83 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945177 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945177: 4-O2 JR. (CPR Mouth Barrier), Eagle Health Supplies (1994) Summary page 1.

## Recalls of this device
- Jul 2, 2014 · Class II · Z-2117-2014: "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.

## Indications for use
This device is used as a physical barrier for mouth to mouth resuscitation The use of this device does not guarantee complete protection from disease transmission.

Source page: https://510kreport.com/device/K052743
Methodology: https://510kreport.com/methodology