# K201666: Single Use Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical Limited.
- Decided: Nov 13, 2020 after 147 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: 1 generation back to K040991 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040991: Ambu Disposable Pressure Manometer, Ambu, Inc. (2004) Summary page 4.

## Indications for use
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient’s airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.

Source page: https://510kreport.com/device/K201666
Methodology: https://510kreport.com/methodology