510(k) · Cleared
ClearedPocket Size Resuscitator/Model: M16201R and M16201A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foremount Ent. Co., Ltd. · CBP Valve, Non-Rebreathing
Cleared on Mar 18, 2005 after a 168-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Mar 18, 2005
- Review
- 168 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK042727 Pocket Size Resuscitator/Model: M16201R and M16201AForemount Ent. Co., Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK081516 Medsource CPR Mask with & Without Oxygen PortMedsource International, LLC · 2008
- Descendant · 2 generations on · 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
- Descendant · 2 generations on · 0 of its ownK102299 CPR Face MaskGenuine First Aid, LLC · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081516Medsource CPR Mask with & Without Oxygen PortMedsource International, LLC · 2008 · cites it directly5descendants
- K112126Genuine First Aid CPR MaskGenuine First Aid, LLC · 2011 · 2 generations on2descendants
- 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
- K102299CPR Face MaskGenuine First Aid, LLC · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042727 | Pocket Size Resuscitator/Model: M16201R and M16201A | Foremount Ent. Co., Ltd. | 2005 | — |
| +1 | K081516 | Medsource CPR Mask with & Without Oxygen Port | Medsource International, LLC | 2008 | — |
| +2 | 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 | — |
| +2 | K102299 | CPR Face Mask | Genuine First Aid, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (6)
2 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?
- Of its descendants, K081516 (Medsource International, LLC, 2008) has gone furthest, with 5 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 Foremount Pocket Size Resuscitator / Model M16201R is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 10kg. The resuscitator with oxygen port is for prescription use.
The Foremount Pocket Size Resuscitator / Model M16201A is indicated for use of adult mouth to mask ventilation via the ventilation mask with non-rebreathing valve for and child whose weight exceeds 10kg. The resuscitator without oxygen port is for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042727: Pocket Size Resuscitator/Model: M16201R and M16201A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042727
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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