510(k) · Cleared
ClearedMedsource CPR Mask with & Without Oxygen Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsource International, LLC · CBP Valve, Non-Rebreathing
Cleared on Aug 26, 2008 as substantially equivalent to K861401 (Laerdal Medical Corp., 1986) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.
- Decided
- Aug 26, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861401 (1986). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK861401 Laerdal Pocket MaskLaerdal Medical Corp. · 1986
- This deviceK081516 Medsource CPR Mask with & Without Oxygen PortMedsource International, LLC · 2008
- Descendant · cites it directly · 2 of its ownK112126 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
- Descendant · cites it directly · 0 of its ownK102299 CPR Face MaskGenuine First Aid, LLC · 2011
- Descendant · cites it directly · 0 of its ownK083418 CPR MaskFirstar Healthcare Co., Ltd. · 2010 · Recalled
Most influential descendants
Showing 5 of 5 · 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 · 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
- K102299CPR Face MaskGenuine First Aid, LLC · 2011 · cites it directly0descendants
- K083418CPR MaskFirstar Healthcare Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861401 | Laerdal Pocket Mask | Laerdal Medical Corp. | 1986 | — |
| 0 (this device) | K081516 | Medsource CPR Mask with & Without Oxygen Port | Medsource International, LLC | 2008 | — |
| +1 | 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 | — |
| +1 | K102299 | CPR Face Mask | Genuine First Aid, LLC | 2011 | — |
| +1 | K083418 | CPR Mask | Firstar Healthcare Co., Ltd. | 2010 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K861401 | Laerdal Pocket MaskSummary page 2…Substantially equivalent Intended Use Laerdal® Pocket Mask With and without oxygen port K861401 Foremount Pocket Size Resuscitator K042727 Tec… | 1986 |
| * | K042727 | Pocket Size Resuscitator/Model: M16201R and M16201ASummary page 2…without oxygen port K861401 Foremount Pocket Size Resuscitator K042727 Technological Characteristics Materials of construction- (Materials of Construct… | 2005 |
| * | — | Spiracle Pocket Size Resuscitator Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MedSource CPR Mask is designed to assist in providing immediate life support
(mouth to mask ventilation) to health emergency victims requiring oxygen
support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081516: Medsource CPR Mask with & Without Oxygen Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081516
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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