510(k) · Cleared
ClearedMercury Cpap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Aug 20, 2009 as substantially equivalent to K013884 (Vygon SA, 2003) after a 155-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Aug 20, 2009
- Review
- 155 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801883 (1980). 7 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 |
|---|---|---|---|---|---|
| −3 | K801883 | Peep Face Mask | Vital Signs, Inc. | 1980 | — |
| −2 | K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow… | Caradyne, Ltd. | 1999 | — |
| −1 | K013884 | Boussignac C.P.a.P. Device | Vygon SA | 2003 | — |
| 0 (this device) | K090710 | Mercury Cpap | Mercury Medical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 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? (1)
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 |
|---|---|---|---|
| * | K013884 | Boussignac C.P.a.P. DeviceSummary page 1…E - attachment, breathing, positive end expiratory pressure Device: Mercury CPAP Predicate Devices: Vygon SA - Boussignac CPAP - K013884 Device Description: The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to el… | 2003 |
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 29 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K013884.
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 CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090710: Mercury Cpap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090710
Report an extraction error
Are you the manufacturer?
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