# K162811: MR Conditional CGA 870

- Pathway: 510(k) (Traditional)
- Applicant: Essex Industries, Inc.
- Decided: Mar 2, 2017 after 147 days
- Product code: CAN (Regulator, Pressure, Gas Cylinder)
- Device class: 1
- Regulation: 21 CFR 868.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Essex CGA 870 oxygen pressure regulator: named in the summary without a submission number

## Indications for use
The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.

Source page: https://510kreport.com/device/K162811
Methodology: https://510kreport.com/methodology