# K110687: Relieva Stratus Pro Microflow Spacer (Frontal)

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Oct 7, 2011 after 210 days
- Product code: KAM (Cannula, Sinus)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912418 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093594: Modification to Relieva Stratus Microflow Spacer, Acclarent, Inc. (2010) Summary page 1.

## Indications for use
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

Source page: https://510kreport.com/device/K110687
Methodology: https://510kreport.com/methodology