# K992101: Criterion 40 or PM 40

- Pathway: 510(k) (Traditional)
- Applicant: Caradyne, Ltd.
- Decided: Jan 6, 2000 after 198 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 K871083 (1987). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871083: CM 5000 Monitor Airway Pressure, Canadian Monaghan, Ltd. (1987) Summary page 1.
- K873953: CM 5000R Remote Airway Pressure, Canadian Monaghan, Ltd. (1987) Summary page 4.
- K925673: Airway Pressure Monitor CM 5000 Ngan, Canadian Monaghan, Ltd. (1993) Summary page 4.
- K931394: CM5000R Remote Indicator, Canadian Monaghan, Ltd. (1993) Summary page 4.

## Most influential descendants
- K221734: Maxtec MaxO2 ME+p (2023), 2 descendants of its own
- K251245: OxyMinder Pro (10310) (2025), 0 descendants of its own
- K231895: Maxtec MaxBlend2+p (2023), 0 descendants of its own
- K182292: VORTRAN APM-Plus (2019), 0 descendants of its own
- K172284: NAPA LP-15 Airway Pressure Monitor (2018), 0 descendants of its own

## Indications for use
Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devcies with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.

Source page: https://510kreport.com/device/K992101
Methodology: https://510kreport.com/methodology