# K040991: Ambu Disposable Pressure Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Jul 22, 2004 after 97 days
- Product code: CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm))
- Device class: 2
- Regulation: 21 CFR 868.2600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110119: Pressure Manometer (2011), 1 descendant of its own
- K201666: Single Use Manometer (2020), 0 descendants of its own
- K153733: VORTRAN Manometer (2016), 0 descendants of its own
- K122627: Gio Digital Pressure Guages (2013), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K040991
Methodology: https://510kreport.com/methodology