# K081778: NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Sep 12, 2008 after 81 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Instrumentation Industries, Inc. - BE 148: named in the summary without a submission number
- (no number) Anesthesia Associates, Inc. Model # 00-199: named in the summary without a submission number

## Most influential descendants
- K180510: NS 120P-TRS Airway Pressure Gauge (2019), 0 descendants of its own

## Indications for use
The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings. These devices are intended to be used by or on the order of a physician. During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. These devices are intended to be used by or on the order of a physician.

Source page: https://510kreport.com/device/K081778
Methodology: https://510kreport.com/methodology