# K182292: VORTRAN APM-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Vortran Medical Technology 1, Inc.
- Decided: Sep 18, 2019 after 391 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: 2 generations back to K871083 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992101: Criterion 40 or PM 40, Caradyne, Ltd. (2000) Summary page 4.

## Indications for use
The VORTRAN® APM-Plus is a multiple-patient-use device intended to monitor a positive-pressure device that connects to an adult or pediatric patient ≥ 10 kg. The device alarms when the conditions (pressure and/or rate, as applicable) are outside of the user selected high and low alarm limits. In PAP Mode, it displays only real-time breathing circuit pressure; in Resuscitator Mode, it displays ventilation parameters in addition to the pressure information. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags, automatic resuscitators, and CPAP, or as an independent backup pressure monitor for devices with pressure measurement capability. The device is designed to be portable and can be used in stationary or portable situations in hospitals and sub-acute institutions. For professional use only.

Source page: https://510kreport.com/device/K182292
Methodology: https://510kreport.com/methodology