510(k) · Cleared
ClearedGenuine First Aid CPR 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 Dec 1, 2011 as substantially equivalent to K081516 (Medsource International, LLC, 2008) and 1 other predicate after a 129-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Dec 1, 2011
- Review
- 129 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K861401 (1986). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK861401 Laerdal Pocket MaskLaerdal Medical Corp. · 1986
- 1 generation backK081516 Medsource CPR Mask with & Without Oxygen PortMedsource International, LLC · 2008
- This deviceK112126 Genuine First Aid CPR MaskGenuine First Aid, LLC · 2011
- Descendant · cites it directly · 1 of its ownK142764 KYOLING CPR Mask with Oxygen Port and Without Oxygen PortHangzhou Jinlin Medical Appliances Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK171961 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen…Xiamen Compower Medical Tech. Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See all- K142764KYOLING CPR Mask with Oxygen Port and Without Oxygen PortHangzhou Jinlin Medical Appliances Co., Ltd. · 2015 · cites it directly1descendant
- K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…Xiamen Compower Medical Tech. Co., Ltd. · 2017 · 2 generations on0descendants
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) | K112126 | Genuine First Aid CPR Mask | Genuine First Aid, LLC | 2011 | — |
| +1 | K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015 | — |
| +2 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port… | Xiamen Compower Medical Tech. Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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? (2)
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 without Oxygen Podr- K081516 LIV Medica CPR Face Mask - K052458 Device Description: Genuine First Aid CPR Face Mask without oxyge… | 2008 |
| * | K052458 | Liv Medica CPR Face MaskSummary page 1…y Regulatory Classification: 21 CFR 868.5870 Predicate Device: Medisource CPR Mask without Oxygen Podr- K081516 LIV Medica CPR Face Mask - K052458 Device Description: Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | 2015 | 1 |
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 4 ancestors has a recall.
- Of its descendants, K142764 (Hangzhou Jinlin Medical Appliances Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 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 CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring 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/K112126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112126: Genuine First Aid CPR Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112126
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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