# K122077: Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Jan 10, 2013 after 178 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Ambu Disposable Pressure Manometer, REF 322004000: named in the summary without a submission number

## Most influential descendants
- K170663: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (2018), 1 descendant of its own
- K210288: Disposable Manual Resuscitator (2021), 0 descendants of its own

## Indications for use
The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patients airway pressure during ventilation. The manometer Is to be used with~ resuscitation systems and Mapleson C breathing circuits.

Source page: https://510kreport.com/device/K122077
Methodology: https://510kreport.com/methodology