# K911344: Cerion Hand Held Oxygen Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Ceramatec, Inc.
- Decided: Jun 18, 1991 after 83 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
131 later devices descend from it; 2 cite it directly.
38 of 132 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
- K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer (1998), 125 descendants of its own
- K020746: Bird Tbird Vela Ventilator (2002), 120 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own

Source page: https://510kreport.com/device/K911344
Methodology: https://510kreport.com/methodology