# K110119: Pressure Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: Jun 10, 2011 after 143 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
Longest line of descent: 6 generations back to K862830 (1986). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954486: Mercury Airway Pressure Manometer, Mercury Medical (1996) Summary page 1.
- K040991: Ambu Disposable Pressure Manometer, Ambu, Inc. (2004) Summary page 1.
- K072021: Neopip Infant Resuscitator, Neoforce Group, Inc. (2007) Summary page 1.
- K092085: Ispira Resuscitation Unit, Neoforce Group, Inc. (2009) Summary page 1.
- K102649: Neopop Infant Resuscitator with Flow Meter, Neoforce Group, Inc. (2011) Summary page 1.
- (no number) Pre-Amendment Pressure Manometer Anesthesia Associates Inc.: named in the summary without a submission number

## Most influential descendants
- K122627: Gio Digital Pressure Guages (2013), 0 descendants of its own

## Indications for use
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.

Source page: https://510kreport.com/device/K110119
Methodology: https://510kreport.com/methodology