510(k) · Cleared
ClearedCPR Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genuine First Aid, LLC · CBP Valve, Non-Rebreathing
Cleared on Mar 18, 2011 as substantially equivalent to K081516 (Medsource International, LLC, 2008) after a 217-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Mar 18, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861401 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861401 | Laerdal Pocket Mask | Laerdal Medical Corp. | 1986 | — |
| −1 | K081516 | Medsource CPR Mask with & Without Oxygen Port | Medsource International, LLC | 2008 | — |
| 0 (this device) | K102299 | CPR Face Mask | Genuine First Aid, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
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 |
|---|---|---|---|
| * | K081516 | Medsource CPR Mask with & Without Oxygen PortSummary page 1…ion: Class 11 Panel: Anesthesiology Regulatory Classification: 21 CFR 868.5870 Predicate Device: Medisource CPR Mask with Oxygen Port -K081516 Device Description: Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way val… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 22.3 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K081516.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102299 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102299: CPR Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102299
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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