# K122627: Gio Digital Pressure Guages

- Pathway: 510(k) (Traditional)
- Applicant: Galemed Corp.
- Decided: Aug 22, 2013 after 359 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: 7 generations back to K862830 (1986). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904935: Respironics' Digital Manometer, Respironics, Inc. (1991) Summary page 1.
- K992101: Criterion 40 or PM 40, Caradyne, Ltd. (2000) Summary page 1.
- K110119: Pressure Manometer, Neoforce Group, Inc. (2011)

## Cited in the summary but kept off the family tree
- K08178: NS Series Airway Pressure Monitors. Number could not be read Summary page 1.

## Indications for use
The Gic Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratorycare devices used in the hospital, and post hospital envirnments. It may be attached by flexible, tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.

Source page: https://510kreport.com/device/K122627
Methodology: https://510kreport.com/methodology