# K102377: Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O; Ventiplus Disposable Manometer 0

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Medical
- Decided: Nov 18, 2010 after 90 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 K961318 (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)
- K961318: 1ST Response Disposable Manometer, Intertech Resources, Inc. (1996) Summary page 1.
- K092687: Venti.Plus Hyperinflation Bag System with Pressure Manometer, A Plus Medical (2009) Summary page 1.

## Indications for use
Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.

Source page: https://510kreport.com/device/K102377
Methodology: https://510kreport.com/methodology