# K140370: Disposable Pressure Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corp
- Decided: Jun 19, 2014 after 125 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: 1 generation back to K003497 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003497: Disposable Pressure Monitor, Engineered Medical Systems (2000) Summary page 1.

## Indications for use
To provide visual indication of a patient's airway pressure during ventilation, It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits. For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home, Physician office, Hospital. Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

Source page: https://510kreport.com/device/K140370
Methodology: https://510kreport.com/methodology