# K003497: Disposable Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Nov 30, 2000 after 17 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K153733: VORTRAN Manometer (2016), 0 descendants of its own
- K143148: Disposable Pressure Manometer (DPM) (2015), 0 descendants of its own
- K140370: Disposable Pressure Manometer (2014), 0 descendants of its own
- K022402: Disposable Pressure Manometer (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K003497
Methodology: https://510kreport.com/methodology