510(k) · Cleared
ClearedLiv Medica CPR Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liv Medica Products Pvt., Ltd. · CBP Valve, Non-Rebreathing
Cleared on Jul 7, 2006 after a 303-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 7, 2006
- Review
- 303 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK052458 Liv Medica CPR Face MaskLiv Medica Products Pvt., Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK112126 Genuine First Aid CPR MaskGenuine First Aid, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK142764 KYOLING CPR Mask with Oxygen Port and Without Oxygen PortHangzhou Jinlin Medical Appliances Co., Ltd. · 2015
- Descendant · 3 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 3 of 3 · See all- K112126Genuine First Aid CPR MaskGenuine First Aid, LLC · 2011 · cites it directly2descendants
- K142764KYOLING CPR Mask with Oxygen Port and Without Oxygen PortHangzhou Jinlin Medical Appliances Co., Ltd. · 2015 · 2 generations on1descendant
- K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…Xiamen Compower Medical Tech. Co., Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052458 | Liv Medica CPR Face Mask | Liv Medica Products Pvt., Ltd. | 2006 | — |
| +1 | K112126 | Genuine First Aid CPR Mask | Genuine First Aid, LLC | 2011 | — |
| +2 | K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015 | — |
| +3 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port… | Xiamen Compower Medical Tech. Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112126 | Genuine First Aid CPR Mask | 2011 | 2 |
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?
- Of its descendants, K112126 (Genuine First Aid, LLC, 2011) has gone furthest, with 2 descendants of its own.
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?
The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve. The face shield serves as a physical barrier, intended to prevent direct mouth contact with the patient's face when providing mouth-to-mouth resuscitation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052458: Liv Medica CPR Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052458
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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