510(k) · Cleared
Recalled · Class II · 2014Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corp. · CBP Valve, Non-Rebreathing
Cleared on Dec 22, 2005 as substantially equivalent to K945177 (Eagle Health Supplies, 1994) after an 83-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Dec 22, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- CBP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945177 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK945177 4-O2 JR. (CPR Mouth Barrier)Eagle Health Supplies · 1994
- This deviceK052743 Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921Dynarex Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945177 | 4-O2 JR. (CPR Mouth Barrier) | Eagle Health Supplies | 1994 | — |
| 0 (this device) | K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921 | Dynarex Corp. | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBP device
- #1 K241366 QualityFlow O2 Series (QualityFLOW O2)…score 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945177 | 4-O2 JR. (CPR Mouth Barrier)Summary page 1…Div. of Anesthesiology, (21 CIFR 868.5870) Class 11 Predicate Device 4-02 Jr. (CPR Mouth Barrier), Eagle Health Supplies 51 0(k) #: K945177 Device Description/ Dynarex CPR Shield with One Way Valve and Barrier Filter, Comparison Model 4921 Intended… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2014 | Class II | Z-2117-2014 | Employee error | "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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBP
129in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBP
No recall names CBP since 2007.
Adverse event reports per year · CBP
1in 2021
MAUDE reports naming product code CBP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 3 | 129 | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052743: Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052743
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026