# K153733: VORTRAN Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Vortran Medical Technology 1, Inc.
- Decided: Sep 16, 2016 after 263 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 K954486 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 4.
- K040991: Ambu Disposable Pressure Manometer, Ambu, Inc. (2004) Summary page 4.
- K003497: Disposable Pressure Monitor, Engineered Medical Systems (2000) Summary page 4.

## Indications for use
The VORTRAN Manometer is a single patient use device intended to provide visual indication of a patient’s airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.

Source page: https://510kreport.com/device/K153733
Methodology: https://510kreport.com/methodology