510(k) · Cleared
ClearedMercury Airway Pressure Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Apr 25, 1996 after a 211-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Apr 25, 1996
- Review
- 211 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK954486 Mercury Airway Pressure ManometerMercury Medical · 1996
- Descendant · cites it directly · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK153733 VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK122627 Gio Digital Pressure GuagesGalemed Corp. · 2013
- Descendant · cites it directly · 0 of its ownK031814 STATCO2METER, Model 10-55372Mercury Medical · 2003
Most influential descendants
Showing 4 of 4 · See all- K110119Pressure ManometerNeoforce Group, Inc. · 2011 · cites it directly1descendant
- K153733VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016 · cites it directly0descendants
- K122627Gio Digital Pressure GuagesGalemed Corp. · 2013 · 2 generations on0descendants
- K031814STATCO2METER, Model 10-55372Mercury Medical · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954486 | Mercury Airway Pressure Manometer | Mercury Medical | 1996 | — |
| +1 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +1 | K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | 2016 | — |
| +2 | K122627 | Gio Digital Pressure Guages | Galemed Corp. | 2013 | — |
| +1 | K031814 | STATCO2METER, Model 10-55372 | Mercury Medical | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 CAP? 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 CAP device
- #1 K201666 Single Use Manometerscore 0.4 · 1 generation · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
3 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, K110119 (Neoforce Group, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CAP devicesCAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CAP
Too few CAP 510(k)s in any year since 2007 to give a median.
Recalls per year · CAP
No recall names CAP since 2007.
Adverse event reports per year · CAP
2in 2025
MAUDE reports naming product code CAP, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H2O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure.
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/K954486 · printed Nov 3, 2026
Cite this page
510(k) Report. “K954486: Mercury Airway Pressure Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K954486
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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