510(k) · Cleared
ClearedAmbu Disposable Pressure Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu, Inc. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Jul 22, 2004 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 97 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK040991 Ambu Disposable Pressure ManometerAmbu, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK201666 Single Use ManometerFlexicare Medical Limited. · 2020
- 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
Most influential descendants
Showing 4 of 4 · See all- K110119Pressure ManometerNeoforce Group, Inc. · 2011 · cites it directly1descendant
- K201666Single Use ManometerFlexicare Medical Limited. · 2020 · cites it directly0descendants
- K153733VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016 · cites it directly0descendants
- K122627Gio Digital Pressure GuagesGalemed Corp. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040991 | Ambu Disposable Pressure Manometer | Ambu, Inc. | 2004 | — |
| +1 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +1 | K201666 | Single Use Manometer | Flexicare Medical Limited. | 2020 | — |
| +1 | K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | 2016 | — |
| +2 | K122627 | Gio Digital Pressure Guages | Galemed Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 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 0.3 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
Ambu Disposable Pressure Manometer will be used to provide visual indication of the patient's airway pressure during ventilation. It may be attached to the manometer port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040991: Ambu Disposable Pressure Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040991
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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