# K130379: Rollins 7 Oxygen Mask

- Pathway: 510(k) (Traditional)
- Applicant: Rollins Medical Solutions, Inc.
- Decided: Oct 9, 2013 after 237 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980407 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080230: Neb-U-Mask System, Models 1895, 1896, Teleflexmedical, Inc. (2008) Summary page 1.

## Indications for use
The Rollins7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.

Source page: https://510kreport.com/device/K130379
Methodology: https://510kreport.com/methodology