# K000959: Criterion 60 or PM 60

- Pathway: 510(k) (Abbreviated)
- Applicant: Caradyne, Ltd.
- Decided: Jun 22, 2000 after 90 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 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
- K023565: Oxicheck (2003), 10 descendants of its own
- K040484: MAXO2+, Model a and AE (2004), 9 descendants of its own
- K063488: MAXO2 CU (2007), 7 descendants of its own
- K122290: Envitec Mysign O Oxygen Measuring Device (2013), 3 descendants of its own
- K072845: Precision Flow (2008), 2 descendants of its own

Source page: https://510kreport.com/device/K000959
Methodology: https://510kreport.com/methodology