510(k) · Cleared
ClearedDisposable Adjustable Peep Valve MR Conditional Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galemed Corp. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Apr 14, 2014 as substantially equivalent to K082092 (Galemed Corp., 2008) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 14, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902062 (1990). 4 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 | K902062 | Peep Valve | Hudson Oxygen Therapy Sales Co. | 1990 | — |
| −1 | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable… | Galemed Corp. | 2008 | — |
| 0 (this device) | K133957 | Disposable Adjustable Peep Valve MR Conditional Use | Galemed Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…Summary page 1…eathing, positive end expiratory pressure 21 CFR 868.5965 Predicate Devices: K082092 - Galemed PEEP valve K08 1266 - Mercury Medical - PEEP Valve MR Device Description The prop… | 2008 |
| * | K081266 | Mercury Medical Peep ValveSummary page 1…pressure 21 CFR 868.5965 Predicate Devices: K082092 - Galemed PEEP valve K08 1266 - Mercury Medical - PEEP Valve MR Device Description The proposed Galemed Disposable Adjustable PEEP valves are identical to the… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 18.1 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K082092.
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. 2014, 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?
Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
For use with neonates to adults.
Environment of Use:
Hospital. extended care facilities, emergency medical services, and patient transport
May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133957: Disposable Adjustable Peep Valve MR Conditional Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133957
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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