# K960861: Omicron Monitor, Delta Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Core-M, Inc.
- Decided: Aug 19, 1996 after 171 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972848: Narkomed Mri Anesthesia System (1997), 1 descendant of its own
- K012446: Office Based Anesthesia Machine Mri, Model Oba-1 Mri (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K960861
Methodology: https://510kreport.com/methodology