510(k) · Cleared
Recalled · Class II · 2016CPR Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Firstar Healthcare Co., Ltd. · CBP Valve, Non-Rebreathing
Cleared on Jul 22, 2010 as substantially equivalent to K081516 (Medsource International, LLC, 2008) and 1 other predicate after a 611-day review. Its family tree reaches back 2 generations to 1986. It has been recalled 2 times.
- Decided
- Jul 22, 2010
- Review
- 611 days
- Class
- Class II
- Product code
- CBP
- Recalls
- 2
- Predicates
- 2
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) | K083418 | CPR Mask | Firstar Healthcare Co., Ltd. | 2010 | — |
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? (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…: Anesthesiology Classification: Class II Regulatory Reference: 21 CFR §868.5870 Single Use: Yes Sterile: No Submission Purpose: New device Predicate Device: *K08 1516 MedSource CPR Mask with Oxygen Port (Prescription Use) manufactured by MEDSOURCE INTERNATIONAL, LLC *K042727… | 2008 |
| * | K042727 | Pocket Size Resuscitator/Model: M16201R and M16201ASummary page 1…New device Predicate Device: *K08 1516 MedSource CPR Mask with Oxygen Port (Prescription Use) manufactured by MEDSOURCE INTERNATIONAL, LLC *K042727 POCKET SIZE RESUSCITATORIMODEL: M16201RAND Ml1 6201 A manufactured by FOREMOUNT ENT. CO., LTD. Indications for Use: T… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2016 | Class II | Z-2133-2016 | Other | Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use. |
| May 16, 2016 | Class II | Z-2132-2016 | Other | First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 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. 2010, 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 FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use.
The FS-104 CPR mask with oxygen port is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083418: 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/K083418
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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