510(k) · Cleared
ClearedMercury Medical Peep Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Enterprizes Dba Mercury Medical · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Mar 5, 2009 after a 304-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 5, 2009
- Review
- 304 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK081266 Mercury Medical Peep ValveMercury Enterprizes Dba Mercury Medical · 2009
- Descendant · cites it directly · 0 of its ownK133957 Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133957Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081266 | Mercury Medical Peep Valve | Mercury Enterprizes Dba Mercury Medical | 2009 | — |
| +1 | K133957 | Disposable Adjustable Peep Valve MR Conditional Use | Galemed Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 BYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133957 | Disposable Adjustable Peep Valve MR Conditional Use | 2014 | 0 |
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, K133957 (Galemed Corp., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 2025
MAUDE reports naming product code BYE, 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 | 1 | — | 4 | 8 |
| 2008 | 1 | — | 2 | 3 |
| 2009 | 3 | 155 | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positive-end expiratory pressure. The device is adjustable from 0-20 cm H 2 0 pressure.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081266: Mercury Medical Peep Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081266
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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