# K093594: Modification to Relieva Stratus Microflow Spacer

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Mar 3, 2010 after 104 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: 3 generations back to K912418 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083574: Relieva Stratus Microflow Spacer, Acclarent, Inc. (2009) Summary page 1.

## Most influential descendants
- K110687: Relieva Stratus Pro Microflow Spacer (Frontal) (2011), 0 descendants of its own

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

Source page: https://510kreport.com/device/K093594
Methodology: https://510kreport.com/methodology